Gemcitabine Hydrochloride, Clofarabine, and Busulfan Before Donor Stem Cell Transplant in Treating Patients With Refractory B-Cell or T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01701986
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Hematopoietic Cell Transplantation Recipient
  • Refractory B-Cell Non-Hodgkin Lymphoma
  • Refractory Hodgkin Lymphoma
  • Refractory T-Cell Non-Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
12 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Allogeneic Bone Marrow Transplantation — PROCEDURE
    Undergo allogeneic BMT
  • Allogeneic Hematopoietic Stem Cell Transplantation — PROCEDURE
    Undergo allogeneic BMT or PBSCT
  • Anti-Thymocyte Globulin — BIOLOGICAL
    Given IV
  • Busulfan — DRUG
    Given IV
  • Clofarabine — DRUG
    Given IV
  • Gemcitabine Hydrochloride — DRUG
    Given IV
  • Mycophenolate Mofetil — DRUG
    Given IV then PO
  • Peripheral Blood Stem Cell Transplantation — PROCEDURE
    Undergo allogeneic PBSCT
  • Pharmacological Study — OTHER
    Correlative studies
  • Rituximab — BIOLOGICAL
    Given IV
  • Tacrolimus — DRUG
    Given IV then PO

Study Details

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.

Key Dates

Start date
Oct 25, 2012
Status verified
Feb 2025
Primary completion
Jun 5, 2024
Completion
Jun 5, 2024

Study Design

Enrollment
64 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (gemcitabine, clofarabine, busulfan, BMT or PBSCT)
    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.

Primary Outcome Measure

Optimal Dose of Gemcitabine Hydrochloride Determined by Dose Limiting Toxicity [ Time Frame: Within 30 days of transplant ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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By research site
M D Anderson Cancer Center· Houston, TX

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