Clinical trial · Interventional
Gemcitabine Plus Busulfan, Melphalan and Hematopoietic Cell Transplant for Advanced Lymphoid Malignancies
Gemcitabine Combined With Busulfan and Melphalan, With Hematopoietic Cell Transplantation, for Patients With Poor-prognosis Advanced Lymphoid Malignancies
NCT00410982CI-TRIAL-00022477completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical research study is to find the highest tolerated dose of gemcitabine that can be given with busulfan and melphalan. The safety of this drug combination will also be studied.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan | Drug | Busulfan | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Hematopoietic Cell Transplantation | Other | — | UNRESOLVED |
| Melphalan | Drug | Melphalan | ALIAS |
| Palifermin | Drug | — | UNRESOLVED |
| Rituximab for Patients with B-Cell Malignancies | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine + Busulfan + Melphalan + HCT
- description
- HCT = Hematopoietic Cell Transplantation
- interventionNames
- Drug: Busulfan
- Drug: Gemcitabine
- Drug: Melphalan
- Other: Hematopoietic Cell Transplantation
- Drug: Rituximab for Patients with B-Cell Malignancies
- Drug: Palifermin
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD) of Gemcitabine with Busulfan + Melphalan
- timeFrame
- Baseline to Day 100 post transplant, up to 115 days
- description
- MTD defined as dose level where one of two participants enrolled at a given time have no dose limiting toxcities (DLT) at that dose level. Continual reassessment from baseline for DLT, monitored daily during hospitalization, weekly to Day 30 and monthly to Day 100. Dose level assessed with each 21-day dose escalation cycle, Gemcitabine delivered Day -8 to Day -5 of 21 day cycle.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 - \<70 years. 2. Patients with lymphoid malignancies who do not qualify for treatment protocols of higher priority: 2.1) Primary refractory/recurrent Hodgkin's disease 2.2) Primary refractory/recurrent non-Hodgkin's lymphoma 2.3) Multiple myeloma beyond first remission or unresponsive to therapy, who do not qualify for higher priority melphalan-based protocols. 3. Adequate renal function, as defined by estimated serum creatinine clearance \>/= 50 ml/min and/or serum creatinine \</= 1.8 mg/dL. 4. Adequate hepatic function, as defined by Serum glutamic oxaloacetic transaminase (SGOT) and/or serum glutamic-pyruvic transaminase (SGPT) \</= 3 \* upper limit of normal; serum bilirubin and alkaline phosphatase \</= 2 \* upper limit of normal. 5. Adequate pulmonary function with forced expiratory volume for 1 second (FEV1), forced vital capacity (FVC) and Carbon Monoxide Diffusing Capacity (DLCO) \>/= 50% of expected corrected for hemoglobin or volume. 6. Adequate cardiac function with left ventricular ejection fraction \>/= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease. 7. Zubrod performance status \<2. 8. Patient should be willing to participate in the study by providing written consent. 9. Negative Beta HCG text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization Exclusion Criteria: 1. Patients with grade \>/= 3 non-hematologic toxicity from previous therapy that has not resolved to grade 1. 2. Patients with prior whole brain irradiation 3. Patients with active hepatitis B virus (HBV), either active carrier (HBsAg +) or viremic (HBV DNA \>=10,000 copies/mL, or \>= 2,000 IU/mL). 4. Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology. 5. Active infection requiring parenteral antibiotics. 6. Human immunodeficiency virus (HIV) infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal CD4 counts 7. Patients having received radiation therapy to head and neck (excluding eyes), and internal organs of chest, abdomen or pelvis in the month prior to enrollment.
References
Publications (1)
- DERIVEDNieto Y, Gruschkus S, Valdez BC, Jones RB, Anderlini P, Hosing C, Popat U, Qazilbash M, Kebriaei P, Alousi A, Saini N, Srour S, Rezvani K, Ramdial J, Barnett M, Gulbis A, Shigle TL, Ahmed S, Iyer S, Lee H, Nair R, Parmar S, Steiner R, Dabaja B, Pinnix C, Gunther J, Cuglievan B, Mahadeo K, Khazal S, Chuang H, Champlin R, Shpall EJ, Andersson BS. Improved outcomes of high-risk relapsed Hodgkin lymphoma patients after high-dose chemotherapy: a 15-year analysis. Haematologica. 2022 Apr 1;107(4):899-908. doi: 10.3324/haematol.2021.278311. PMID 33951890