Acute Myeloid Leukemia Clinical Trial

A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies

Summary

This trial will look at a drug called SEA-CD70 with and without azacitidine, to find out if it is safe for patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). It will study SEA-CD70 to find out what its side effects are and if it works for AML and MDS. A side effect is anything the drug does besides treating cancer.

This study will have six groups or "parts."

Part A will find out how much SEA-CD70 should be given to patients.
Part B will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat patients with MDS.
Part C will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat patients with AML.
Part D will find out how much SEA-CD70 with azacitidine should be given to patients.
Part E will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat patients with MDS that has not been treated.
Part F will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat patients with MDS or AML.

View Full Description

Full Description

This is a phase 1, open-label, multicenter, dose-finding, and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of SEA-CD70 monotherapy and SEA-CD70 in combination with azacitidine in adults with myeloid malignancies. The study will be conducted in up to 6 parts.

Part A is a dose-escalation cohort designed to identify the MTD or recommended expansion dose of SEA-CD70 monotherapy in participants with relapsed/refractory (hypomethylating agent [HMA]-failure) MDS.
Part B is an expansion cohort designed to evaluate the safety and tolerability of SEA-CD70 monotherapy in participants with relapsed/refractory (HMA-failure) MDS.
Part C is an expansion cohort designed to evaluate the safety and tolerability of SEA-CD70 monotherapy in participants with relapsed/refractory AML.
Part D contains dose-finding/dose optimization cohorts designed to evaluate the safety/tolerability and identify the recommended expansion dose of SEA-CD70 in combination with azacitidine in participants with 1) relapsed/refractory (HMA-failure) MDS or AML arising from MDS, and 2) previously untreated higher-risk (IPSS intermediate-2 or high risk) MDS.
Part E is an expansion cohort designed to evaluate the safety and tolerability of SEA-CD70 in combination with azacitidine in participants with previously untreated higher-risk (IPSS intermediate-2 or high risk) MDS.
Part F is an expansion cohort designed to evaluate the safety and tolerability of SEA-CD70 in combination with azacitidine in participants with relapsed/refractory (HMA-failure) MDS or AML arising from MDS.

View Eligibility Criteria

Eligibility Criteria

Part A Inclusion Criteria

Participants with cytologically/histologically confirmed MDS according to the 2016 World Health Organization (WHO) classification with the following:

Measurable disease per WHO MDS with excess blasts criteria as defined either:

5%-9% blasts in the bone marrow or 2%-4% blasts in the peripheral blood or
10%-19% blasts in the bone marrow or 5%-19% blasts in the peripheral blood
MDS that is relapsed or refractory and must not have other therapeutic options known to provide clinical benefit in MDS available.

Treatment failure after prior hypomethylating agent (HMA) therapy for MDS, defined as one of the following:

Progression (per 2006 International Working Group [IWG] criteria) at any time after initiation of HMA therapy.
Lack of response (failure to achieve complete remission [CR], partial response [PR], or hematologic improvement [HI] per 2006 IWG criteria) after at least 6 cycles of azacitidine (or equivalent HMA) or 4 cycles of decitabine (or equivalent HMA).
Relapse after achievement of CR, PR, or HI (per 2006 IWG criteria).
Intolerance of HMA (Grade 3 or higher non-hematologic toxicity leading to treatment discontinuation).
Participants with isolated 5q-/5q- syndrome must have progressed, failed, relapsed, or not tolerated lenalidomide in addition to HMA.
Must be off HMA therapy ≥ 2 weeks and must be off any other treatments for MDS for ≥ 4 weeks prior to first dose of SEA-CD70; growth factors and transfusions are allowed before and during the study as clinically indicated
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Part B Inclusion Criteria

Participants with cytologically/histologically confirmed MDS according to the WHO classification with the following:

Measurable disease per WHO MDS with excess blasts (MDS-EB) criteria as defined either:

5%-9% blasts in the bone marrow or 2%-4% blasts in the peripheral blood, or
10%-19% blasts in the bone marrow or 5%-19% blasts in the peripheral blood
MDS that is relapsed or refractory and must not have other therapeutic options known to provide clinical benefit in MDS available.

Treatment failure after prior HMA therapy for MDS defined as one of the following:

Progression (per 2006 IWG criteria) at any time after initiation of HMA therapy.
Lack of response (failure to achieve CR, PR, or HI per 2006 IWG criteria) after at least 6 cycles of azacitidine or 4 cycles of decitabine.
Relapse after achievement of CR, PR, or HI (per 2006 IWG criteria).
Intolerance of HMA (Grade 3 or higher non-hematologic toxicity leading to treatment discontinuation).
Participants with isolated 5q-/5q- syndrome must have progressed, failed, relapsed, or not tolerated lenalidomide in addition to HMA.
Must be off HMA therapy ≥ 2 weeks and must be off any other systemic treatments for MDS for ≥ 4 weeks prior to first dose of SEA-CD70; growth factors and transfusions are allowed before and during the study as clinically indicated.
ECOG Performance Status of 0-2

Part C Inclusion Criteria

Participants with relapsed or refractory AML according to the WHO 2016 classification (except for acute promyelocytic leukemia [APL]):

Who have received either 2 or 3 previous regimens to treat active disease. Post-remission treatments, intrathecal chemotherapy, and radiotherapy are not considered previous regimens.

Who have received 1 previous regimen to treat active disease and have at least one of the following:

Age > 60 and ≤75 years.
Primary resistant AML (defined as failure to achieve CR after 1-2 courses of induction therapy)
First CR duration <6 months
Adverse-risk per European Leukemia Net (ELN) genetic risk stratification
Secondary AML (prior history of MDS or therapy-related)
Age 18-75 years
ECOG performance status of 0-2

Parts D and F Inclusion Criteria

Participants with one of the following confirmed diagnoses:

MDS with excess blasts (MDS-EB), defined as either:

5%-9% blasts in the bone marrow or 2%-4% blasts in the peripheral blood (MDS-EB-1), or
10%-19% blasts in the bone marrow or 5%-19% blasts in the peripheral blood (MDS-EB-2)
AML with ≤ (less than or equal to) 30% blasts in the peripheral blood or bone marrow, with known history of MDS
Disease which has relapsed, failed to respond after minimum of 6 cycles, or progressed following an HMA in the immediately preceding line of therapy.
Eligible for continued therapy with azacitidine
Must be off any other systemic treatment for AML/MDS. Must be off HMA therapy ≥ (greater than or equal to) 2 weeks and any other systemic treatments for MDS for ≥ (greater than or equal to) 4 weeks prior to first dose of SEA-CD70
ECOG Performance Status 0-2

Parts D and E Inclusion Criteria

Participants with previously untreated, cytologically/histologically confirmed MDS according to WHO classification with the following:

Measurable disease per WHO MDS with excess blasts (MDS-EB) criteria as defined either:

5%-9% blasts in the bone marrow or 2%-4% blasts in the peripheral blood (MDS-EB-1), or
10%-19% blasts in the bone marrow or 5%-19% blasts in the peripheral blood (MDS-EB-2)
Participants with higher-risk MDS per International Prognostic Scoring System (IPSS)
ECOG Performance Status 0-2

Exclusion Criteria (All Parts)

History of another malignancy within 3 years before the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
Previous exposure to CD70-targeted agents
Prior allogeneic hematopoietic stem cell transplant, for any condition
Central nervous system leukemia based on imaging or documented positive cytology in cerebral spinal fluid
History of clinically significant sickle cell anemia, autoimmune hemolytic anemia, or idiopathic thrombocytopenic purpura
Parts D and F only: Prior oral HMA or oral HMA-combinations

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

140

Study ID:

NCT04227847

Recruitment Status:

Recruiting

Sponsor:

Seagen Inc.

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There are 19 Locations for this study

See Locations Near You

University of Alabama at Birmingham
Birmingham Alabama, 35249, United States More Info
Pankit Vachhani
Principal Investigator
City of Hope National Medical Center
Duarte California, 91010, United States More Info
Rochelle Hernandez
Contact
626-218-0247
[email protected]
Ahmed Aribi
Principal Investigator
UCLA Department of Medicine - Hematology & Oncology
Los Angeles California, 90095, United States More Info
Vladimir Kustanovich
Contact
310-794-1966
[email protected]
Bruck Habtemariam
Contact
310-794-0242
[email protected]
Caspian Oliai
Principal Investigator
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States More Info
James Vick
Contact
720-754-4800
[email protected]
Marcello Rotta
Principal Investigator
University of Kansas Cancer Center
Fairway Kansas, 66205, United States More Info
Abdulraheem Yacoub
Principal Investigator
Norton Cancer Institute
Louisville Kentucky, 40207, United States More Info
Joshua Roberts
Contact
502-899-2673
[email protected]
Don Stevens
Principal Investigator
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Meghan Burke
Contact
617-726-1599
[email protected]
Amir Fathi
Principal Investigator
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States More Info
Pelavala Elavalakanar
Contact
617-667-9920
[email protected]
Jessica Liegel
Principal Investigator
Karmanos Cancer Institute / Wayne State University
Detroit Michigan, 48201, United States More Info
Mary Domagalski
Contact
313-576-9767
[email protected]
Jay Yang
Principal Investigator
Case Western Reserve University / University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States More Info
Susan Ackerman
Contact
216-286-4150
[email protected]
Benjamin Tomlinson
Principal Investigator
Cleveland Clinic, The
Cleveland Ohio, 44195, United States More Info
Taussig Research Group
Contact
866-223-8100
[email protected]
Anjali Advani
Principal Investigator
James Cancer Hospital / Ohio State University
Columbus Ohio, 43210, United States More Info
Lisa Brenner
Contact
614-293-7843
[email protected]
Shayla Thompson
Contact
614-293-5655
[email protected]
Nicole Grieselhuber
Principal Investigator
Medical University of South Carolina/Hollings Cancer Center
Charleston South Carolina, 29425, United States More Info
Shanta Salzer
Contact
843-792-1463
[email protected]
Praneeth Baratam
Principal Investigator
Saint Francis Hospital / Bon Secours - South Carolina
Greenville South Carolina, 29607, United States More Info
Sharon (Nikki) Thompson
Contact
864-603-6238
[email protected]
Sharif Khan
Principal Investigator
Tennessee Oncology-Nashville/Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Texas Oncology - Fort Worth
Dallas Texas, 75246, United States More Info
Joyce Ghormley
Contact
214-818-8961
[email protected]
Edward Pearson
Principal Investigator
MD Anderson Cancer Center / University of Texas
Houston Texas, 77030, United States More Info
Bailey Mirabella
Contact
[email protected]
Guillermo Garcia-Manero
Principal Investigator
Swedish Cancer Institute
Seattle Washington, 98104, United States More Info
Neil Bailey
Contact
206-386-6000
[email protected]
Raya Mawad
Principal Investigator
Leids Universitair Medisch Centrum ( LUMC)
Leiden Other, 2333 , Netherlands More Info
Hendrik Veelken
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

140

Study ID:

NCT04227847

Recruitment Status:

Recruiting

Sponsor:


Seagen Inc.

How clear is this clinincal trial information?

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