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
Hematopoietic Cell Transplantation Recipient, Refractory B-Cell Non-Hodgkin Lymphoma, Refractory Hodgkin Lymphoma
About this trial
This is an interventional treatment trial for Hematopoietic Cell Transplantation Recipient
Eligibility Criteria
Inclusion Criteria:
- Patients with refractory B-cell or T-cell non-Hodgkin's lymphoma or Hodgkin's lymphoma who are eligible for allogeneic transplantation
- An 8/8 human leukocyte antigen (HLA) matched (high resolution typing at A, B, C, DRB1) sibling or unrelated donor
- Left ventricular ejection fraction (EF) >= 45%
- Forced expiratory volume in one second (FEV1) >= 50%
- Forced vital capacity (FVC) >= 50%
- Diffusing capacity of the lung for carbon monoxide (DLCO) >= 50%
- Estimated serum creatinine clearance >= 50 ml/min (using the Cockcroft-Gault formula)
- Serum creatinine =< 1.6 mg/dL
- Serum bilirubin =< 2 x upper limit of normal
- Serum glutamate pyruvate transaminase (SGPT) =< 2 x upper limit of normal
- 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
- Men and women of reproductive potential must agree to follow accepted birth control methods for the duration of the study; female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study; male subject agrees to use an acceptable method for contraception for the duration of the study
Exclusion Criteria:
- Patient with active central nervous system (CNS) disease
- Pregnancy (positive beta human chorionic gonadotropin [HCG] test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization) or currently breast-feeding; pregnancy testing is not required for post-menopausal or surgically sterilized women
- Active hepatitis B, either active carrier (hepatitis B virus surface antigen [HBsAg] +) or viremic (hepatitis B virus [HBV] deoxyribonucleic acid [DNA] >= 10,000 copies/mL, or >= 2,000 IU/mL)
- Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology
- Human immunodeficiency virus (HIV) infection
- Active uncontrolled bacterial, viral or fungal infections
- Exposure to other investigational drugs within 2 weeks before enrollment
- Grade >= 3 non-hematologic toxicity from previous therapy that has not resolved to =< grade 1
- Radiation therapy to head and neck (excluding eyes), and internal organs of chest, abdomen or pelvis in the month prior to enrollment
- Prior whole brain irradiation
- Prior autologous stem-cell transplant (SCT) in the prior 3 months
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
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.