Non Hodgkin Lymphoma Clinical Trial

Reduced-intensity, Related-donor Bone Marrow Transplantation Followed by High-dose Cyclophosphamide for Hematologic Cancers

Summary

This research is being done to learn more about reduced-intensity bone marrow transplantation (BMT), also known as a "mini" transplant for patients with blood cancers, using bone marrow from a relative.

The main goal of the study is to determine how quickly the donor's bone marrow "takes" in your body. Other goals include describing how many people accept the bone marrow and how quickly the blood counts come up; describing Graft-versus-host disease (GVHD) and other complications; and describing how many people survive without progressive cancer and survive overall

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Full Description

At the present time there are few or no cures for people with cancer of the blood or lymph glands outside of a bone marrow transplant (BMT). BMT has developed over several decades of research as an effective treatment of various malignant and nonmalignant hematologic diseases.

This research is being done to learn more about reduced-intensity bone marrow transplantation (BMT), also known as a "mini" transplant for patients with blood cancers, using bone marrow from a relative. The bone marrow for this transplant comes from a relative who is a half-match or "haplo" match to you. Possible donors include parents, siblings, and children.

"Mini" transplants have been given to many people with various cancers but are considered experimental. Over 200 people at Johns Hopkins have received mini transplants with high doses of cyclophosphamide after the transplant. However, the chemotherapy combination and other treatment given before those transplants were different from what is in this study. Although all of the chemotherapy and immune-lowering drugs used in this study are approved by the Food and Drug Administration (FDA), the combination of medications used in this study are not FDA approved and are experimental.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

First-degree related donor who is at minimum HLA haploidentical

Eligible diagnoses:

Low-grade non-Hodgkin's lymphoma or plasma cell neoplasm that has progressed during multiagent therapy, failed at least two prior therapies (excluding single agent rituximab and single agent steroids), or in the case of lymphoma undergone histological conversion:

Follicular grade 1 or 2 lymphoma
Follicular lymphoma not otherwise specified
Marginal zone (or MALT) lymphoma
Lymphoplasmacytic lymphoma / Waldenstrom's macroglobulinemia
Hairy cell leukemia
Small lymphocytic lymphoma (SLL) or chronic lymphocytic leukemia (CLL)
Prolymphocytic leukemia
Low grade B-cell lymphoma, unspecified
Multiple myeloma
Plasma cell leukemia
Poor-risk SLL or CLL, defined by an 11q or 17p deletion, histological conversion, or disease progression < 6 months after a purine analog-containing regimen

Aggressive lymphoma that has failed at least one prior regimen of multiagent chemotherapy, and patient is either ineligible for autologous BMT or autologous BMT is not recommended:

Hodgkin lymphoma
Follicular grade 3 lymphoma
Mantle cell lymphoma or leukemia
Diffuse large B-cell lymphoma (excluding primary CNS lymphoma). Eligible subtypes include primary mediastinal large B-cell lymphoma, T-cell rich large B-cell lymphoma, and large B-cell lymphoma not otherwise specified.
Burkitt's lymphoma/leukemia
Atypical Burkitt's lymphoma/leukemia (high grade B-cell lymphoma, unclassified, including that with features intermediate between Burkitt's and diffuse large B-cell lymphoma)
Anaplastic large cell lymphoma
Plasmablastic lymphoma
Peripheral T-cell lymphoma
Relapsed or refractory acute leukemia in second or subsequent remission
Poor-risk acute leukemia in first remission

AML with at least one of the following:

AML arising from MDS or a myeloproliferative disorder, or secondary AML
Presence of Flt3 internal tandem duplications
Poor-risk cytogenetics

Primary refractory disease

ALL (leukemia and/or lymphoma) with at least one of the following:
Adverse cytogenetics
Clear evidence of hypodiploidy

Primary refractory disease

Biphenotypic leukemia
MDS with at least one of the following features:
Poor-risk cytogenetics
IPSS score of INT-2 or greater
Treatment-related MDS
MDS diagnosed before age 21 years
Progression on or lack of response to standard DNA-methyltransferase inhibitor therapy
Life-threatening cytopenias, including those generally requiring greater than weekly transfusions
Interferon- or imatinib-refractory CML in first chronic phase, or non-blast crisis CML beyond first chronic phase
Philadelphia chromosome negative myeloproliferative disease (including myelofibrosis)
Chronic myelomonocytic leukemia

Juvenile myelomonocytic leukemia

For patients with SLL, CLL, or prolymphocytic leukemia, < 20% of bone marrow cellularity involved by this process
Adequate end-organ function:
Left ventricular ejection fraction greater than or equal to 35%
Bilirubin ≤ 3.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST < 5 x ULN

FEV1 and FVC > 40% of predicted; or in pediatric patients, if unable to perform pulmonary function tests due to young age, oxygen saturation >92% on room air

ECOG performance status < 2 or Karnofsky or Lansky score > 60

Exclusion Criteria:

Pregnant or breast-feeding
Uncontrolled infection Note: Infection is permitted if there is evidence of response to medication. Eligibility of HIV infected patients will be determined on a case-by-case basis.
Any previous BMT within 3 months prior to start of conditioning
Active extra-medullary leukemia or known active Central Nervous System (CNS) involvement by malignancy. Such disease treated into remission is permitted.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

15

Study ID:

NCT01135329

Recruitment Status:

Terminated

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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There is 1 Location for this study

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The Sydney Kimmel Comprehensive Cancer Center
Baltimore Maryland, 21231, United States

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Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

15

Study ID:

NCT01135329

Recruitment Status:

Terminated

Sponsor:


Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

How clear is this clinincal trial information?

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