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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00410982 |
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 I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized 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 |
| Estimated Enrollment: | 143 |
| Study Start Date: | December 2006 |
| Estimated Primary Completion Date: | December 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:
Drug: Gemcitabine
Day -8 = 75 mg/m^2 Intravenous bolus; Day -3 = 75 mg/m^2 Intravenous bolus.
Other Names:
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:
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Yago Nieto, MD, PhD | M.D. Anderson Cancer Center |
More Information
| 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: | August 30, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
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 |
|
Neoplasms Leukemia Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders |
Hematologic Diseases Hemorrhagic Disorders Busulfan Melphalan Gemcitabine Rituximab Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |