Chemotherapy + Stem Cell Transplant for Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen byYago L Nieto, MD,PHD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase I/II trial studies the side effects and best dose of gemcitabine hydrochloride, clofarabine, and busulfan before donor stem cell transplant and to see how well it works in treating patients with B-cell or T-cell non-Hodgkin lymphoma or Hodgkin lymphoma that does not respond to treatment. Giving chemotherapy before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.

Research Team

Yago L Nieto, MD,PHD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for patients with B-cell or T-cell non-Hodgkin lymphoma or Hodgkin lymphoma that's resistant to treatment. Participants must have a matched donor for stem cell transplant, good heart and lung function, normal liver and kidney tests, and agree to birth control methods. Excluded are those with HIV, uncontrolled infections, severe recent toxicity from treatments, certain prior radiation therapies or transplants, active brain disease, pregnancy/breastfeeding women, and active hepatitis.

Inclusion Criteria

Voluntary signed Institutional Review Board (IRB)-approved informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care

Left ventricular ejection fraction (EF) >= 45%

Serum glutamate pyruvate transaminase (SGPT) =< 2 x upper limit of normal

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Exclusion Criteria

I have severe liver damage or cirrhosis due to hepatitis C.

I do not have any ongoing serious infections.

I have not had radiation therapy to my head, neck, chest, abdomen, or pelvis in the last month.

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Treatment Details

Interventions

Allogeneic Bone Marrow Transplantation (Procedure)
Allogeneic Hematopoietic Stem Cell Transplantation (Procedure)
Anti-Thymocyte Globulin (Biological)
Busulfan (Alkylating agents)
Clofarabine (Anti-metabolites)
Gemcitabine Hydrochloride (Anti-metabolites)
Mycophenolate Mofetil (Drug)
Rituximab (Biological)
Tacrolimus (Drug)

Trial OverviewThe study is testing the effectiveness of chemotherapy drugs gemcitabine hydrochloride, clofarabine, busulfan before a donor stem cell transplant in treating stubborn lymphomas. It aims to find the best dose while assessing how well it prepares patients' bodies for accepting donor stem cells which can help rebuild healthy blood cells.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (gemcitabine, clofarabine, busulfan, BMT or PBSCT)Experimental Treatment11 Interventions

PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8. TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0.

Busulfan is already approved in Canada, Japan for the following indications: