Gemcitabine Plus Busulfan, Melphalan and Hematopoietic Cell Transplant for Advanced Lymphoid Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00410982
First received: December 11, 2006
Last updated: September 24, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Leukemia
Lymphoma
Myeloma
Drug: Busulfan
Drug: Gemcitabine
Drug: Melphalan
Other: Hematopoietic Cell Transplantation
Drug: Rituximab for Patients with B-Cell Malignancies
Drug: Palifermin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Gemcitabine Combined With Busulfan and Melphalan, With Hematopoietic Cell Transplantation, for Patients With Poor-prognosis Advanced Lymphoid Malignancies

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) of Gemcitabine with Busulfan + Melphalan. [ Time Frame: Continual reassessment: Baseline to Dose Limiting Toxicity, monitored daily during hospitalization, weekly to Day 30 and monthly to Day 100 ] [ Designated as safety issue: Yes ]

Enrollment: 145
Study Start Date: December 2006
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcitabine + Busulfan + Melphalan + HCT
HCT = Hematopoietic Cell Transplantation
Drug: Busulfan
Day -10 = 32 mg/m^2 Intravenous Test Dose; Days -8 thru -5 = 105 mg/m^2 Intravenous
Other Names:
  • Busulfex
  • Myleran
Drug: Gemcitabine
Day -8 = 75 mg/m^2 Intravenous bolus; Day -3 = 75 mg/m^2 Intravenous bolus.
Other Names:
  • Gemzar
  • Gemcitabine Hydrochloride
Drug: Melphalan
Day -3 and Day -2 = 60 mg/m^2 Intravenous.
Other Name: Alkeran
Other: Hematopoietic Cell Transplantation
Infusion of stem cells on Day 0.
Other Names:
  • Stem Cell Infusion
  • HCT
Drug: Rituximab for Patients with B-Cell Malignancies
375 mg/m^2 Intravenous on Days 1 and 8.
Other Name: Rituxan
Drug: Palifermin
60 microgram/kg by vein on Days -13 to -11 and Days 0, +1, +2
Other Name: Kepivance

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 SGOT and/or SGPT </= 3 x upper limit of normal; serum bilirubin and alkaline phosphatase </= 2 x upper limit of normal.
  5. Adequate pulmonary function with FEV1, FVC and 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, 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. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410982

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Yago Nieto, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00410982     History of Changes
Other Study ID Numbers: 2006-0803
Study First Received: December 11, 2006
Last Updated: September 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Lymphoid Malignancies
Hodgkin's Disease
Non-Hodgkin's Lymphoma
Acute Lymphoblastic Leukemia
Chronic Lymphocytic Leukemia
Hematopoietic Cell Transplantation
Myeloma
Leukemia
Lymphoma
Busulfan
Busulfex
Myleran
Gemcitabine
Gemcitabine Hydrochloride
Gemzar
Melphalan
Alkeran

Additional relevant MeSH terms:
Leukemia
Lymphoma
Neoplasms
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Busulfan
Gemcitabine
Melphalan
Alkylating Agents
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014