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
1 other identifier
interventional
145
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 leukemia
Started Dec 2006
Typical duration for phase_1 leukemia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 11, 2006
CompletedFirst Posted
Study publicly available on registry
December 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedJune 3, 2016
September 1, 2012
5.8 years
December 11, 2006
June 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose (MTD) of Gemcitabine with Busulfan + Melphalan
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.
Baseline to Day 100 post transplant, up to 115 days
Study Arms (1)
Gemcitabine + Busulfan + Melphalan + HCT
EXPERIMENTALHCT = Hematopoietic Cell Transplantation
Interventions
Day -10 = 32 mg/m\^2 Intravenous Test Dose; Days -8 thru -5 = 105 mg/m\^2 Intravenous
Day -8 = 75 mg/m\^2 Intravenous bolus; Day -3 = 75 mg/m\^2 Intravenous bolus.
Day -3 and Day -2 = 60 mg/m\^2 Intravenous.
Infusion of stem cells on Day 0.
375 mg/m\^2 Intravenous on Days 1 and 8.
60 microgram/kg by vein on Days -13 to -11 and Days 0, +1, +2
Eligibility Criteria
You may qualify if:
- Age 18 - \<70 years.
- 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.
- Adequate renal function, as defined by estimated serum creatinine clearance \>/= 50 ml/min and/or serum creatinine \</= 1.8 mg/dL.
- 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.
- 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.
- Adequate cardiac function with left ventricular ejection fraction \>/= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- Zubrod performance status \<2.
- Patient should be willing to participate in the study by providing written consent.
- Negative Beta HCG text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization
You may not qualify if:
- Patients with grade \>/= 3 non-hematologic toxicity from previous therapy that has not resolved to grade 1.
- Patients with prior whole brain irradiation
- Patients with active hepatitis B virus (HBV), either active carrier (HBsAg +) or viremic (HBV 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.
- Active infection requiring parenteral antibiotics.
- Human immunodeficiency virus (HIV) infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal CD4 counts
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Nieto 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: 33951890DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yago Nieto, MD, PhD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2006
First Posted
December 13, 2006
Study Start
December 1, 2006
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
June 3, 2016
Record last verified: 2012-09