Non Hodgkin Lymphoma Clinical Trial

Haplo Peripheral Blood Sct In GVHD Prevention

Summary

This research study is studying the RGI-2001 for preventing Graft-vs-Host Disease (GVHD) in people with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS), myeloproliferative disorders (MPN), chronic myelomonocytic leukemic (CMML), chemosensitive hodgkin lymphoma (HL), or Non-Hodgkin lymphoma (NHL).who will have a blood stem cell transplantation.

GVHD is a condition in which cells from the donor's tissue attack the organs.
RGI-2001 is an investigational treatment

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Full Description

This is a pilot study in subjects undergoing reduced-intensity haploidentical peripheral blood stem cell transplantation who will receive graft-versus-host disease prevention with post-transplant cyclophosphamide, followed by sirolimus, mycophenolate mofetil, and RGI-2001.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

The standard of care drugs of fludarabine, cyclophosphamide, melphalan, radiation, sirolimus, and mycophenolate mofetil are all FDA approved.

Eligible Participants will be placed in 1 of 2 groups, per physicians discretion:

Regimen #1 :

Before stem cell transplant:Fludarabine + Cyclophosphamide + Radiation
After stem cell transplant: Cyclophosphamide + Sirolimus +Mycophenolate mofetil + RGI-2001

Regimen #2

Before stem cell transplant: fludarabine + melphalan + radiation
After stem cell transplant: cyclophosphamide + sirolimus +Mycophenolate mofetil + RGI-2001
A total of 20 participants will be enrolled to this trial
The U.S. Food and Drug Administration (FDA) has not approved RGI-2001 as a treatment for any disease.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Men or women ≥ 18 and ≤ 80 years old

Diagnosis of hematological malignancy:

Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) in morphologic complete remission
Myelodysplastic syndrome (MDS), myeloproliferative disorders (MPN), or chronic myelomonocytic leukemic (CMML) with < 5% blasts in blood or bone marrow
Chemosensitive Hodgkin lymphoma (HL) or Non-Hodgkin lymphoma (NHL)
Patients must be undergoing haploidentical allogeneic hematopoietic cell transplantation, defined as 1st or 2nd degree relative with at least 5/10 matching at HLA-A, -B, -C, DR, and DQ.
ECOG performance status ≤2

Patients with adequate physical function as measured by:

Cardiac: Left ventricular ejection fraction at rest must be ≥ 40%, or shortening fraction >25%

Hepatic:

Bilirubin ≤ 2.5 mg/dL, except for patients with Gilbert's syndrome or hemolysis
ALT, AST, and Alkaline Phosphatase < 5 x ULN
Renal: Serum creatinine within normal range, or if serum creatinine is outside normal range, then renal function (measured or estimated creatinine clearance or GFR) ≥ 40mL/min/1.73m2
Pulmonary: DLCO (corrected for hemoglobin), FEV1 and FVC ≥ 50% predicted
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Prior allogeneic hematopoietic stem cell transplantation. (Patients may have received a prior autologous hematopoietic stem cell transplant.)
Participants who are receiving any other investigational agents within 14 days prior to RGI-2001 dosing. Thus, participants must stop investigational agents by Day -9 prior to transplant.
Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, recent myocardial infarction or stroke, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Patients with active or uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
Planned use of prophylactic donor lymphocyte infusion (DLI) therapy.
Pregnant and breast-feeding women are ineligible because they are not eligible for hematopoietic stem cell transplantation.
HIV-positive participants and patients with active Hepatitis B or C are ineligible

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

25

Study ID:

NCT04473911

Recruitment Status:

Active, not recruiting

Sponsor:

Zachariah Michael DeFilipp

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There is 1 Location for this study

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Massachusetts General Hospital
Boston Massachusetts, 02115, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

25

Study ID:

NCT04473911

Recruitment Status:

Active, not recruiting

Sponsor:


Zachariah Michael DeFilipp

How clear is this clinincal trial information?

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