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High-Dose Gemcitabine, Busulfan and Melphalan for Patients With Refactory Hodgkin's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01200329
Recruitment Status : Completed
First Posted : September 13, 2010
Results First Posted : December 16, 2019
Last Update Posted : December 16, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn if the combination of gemcitabine, busulfan, and melphalan, when given before a stem cell transplant, can help to control refractory Hodgkin's disease. The safety of this study treatment will also be studied.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: Gemcitabine Drug: Busulfan Drug: Melphalan Procedure: Stem Cell Transplantation Drug: Palifermin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High-Dose Gemcitabine, Busulfan and Melphalan With Hematopoietic Cell Support for Patients With Relapsed/Refractory Hodgkin's Disease
Actual Study Start Date : June 2011
Actual Primary Completion Date : December 6, 2018
Actual Study Completion Date : December 6, 2018


Arm Intervention/treatment
Experimental: Gemcitabine + Busulfan + Melphalan
Gemcitabine 2775 mg/m2 by vein over about 3 hours on days -8 and -3. Busulfan 32 mg/m2 test dose with PKs as outpatient and on day -10 as inpatient. AUC 4,000 by vein over about 3 hours on days -8 to -5. Melphalan 60 mg/m2 by vein over about 30 minutes on days -3 and -2. Palifermin 60 mg/kg by vein over 30 seconds daily, Days -12 to -10 and Days 0 to 2. Infusion of stem cells on Day 0.
Drug: Gemcitabine
2775 mg/m2 by vein over about 3 hours on days -8 and -3.
Other Names:
  • Gemcitabine Hydrochloride
  • Gemzar

Drug: Busulfan

32 mg/m2 test dose with PKs as outpatient and on day -10 as inpatient

AUC 4,000 by vein over about 3 hours on days -8 to -5.

Other Names:
  • Busulfex
  • Myleran

Drug: Melphalan
60 mg/m2 by vein over about 30 minutes on days -3 and -2.
Other Name: Alkeran

Procedure: Stem Cell Transplantation
Infusion of stem cells on Day 0.
Other Name: SCT

Drug: Palifermin
60 mg/kg by vein over 30 seconds daily, Days -12 to -10 and Days 0 to 2.
Other Name: Kepivance




Primary Outcome Measures :
  1. Event-free Survival (EFS) of Patients [ Time Frame: Enrollment up to 2 years post transplant ]
    The event-free survival (EFS) of patients with poor prognosis relapse or refractory Hodgkin's disease (HD) after high-dose chemotherapy (HDC) with Gemcitabine/Busulfan/Melphalan (GemBuMel). Event is defined as relapse, tumor progression or death.Progression free survival is the length of time during and after the treatment of disease that a patient lives with the disease but it does not get worse. Toxicity is defined as the treatment related mortality (TRM) rate, which will be evaluated within 30 days post transplant, and this rate will be compared with the 5% maximum rate. For EFS analysis, patients who experience the tumor relapse, disease progression, or death will be considered to be an event.


Secondary Outcome Measures :
  1. Overall Survival (OS) of These Patients. [ Time Frame: Beyond 100 days post transplant up to 84 months. ]
    The overall survival is the length of time from the start of treatment (Auto SCT) for the cancer, that patients are diagnosed with are still alive until date of first documented progression or date of death from any cause. It is measured in months and assessed up to 84 months.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 12 to 70 years
  2. Patients with relapsed Hodgkin's disease and one or more of the following: 1) Less than complete response to first-line chemotherapy, 2) Relapse within 12 months of completion of first-line chemotherapy, 3) Relapse within a prior irradiation field, 4) Less than complete metabolic response to second-line chemotherapy, 5) Second relapse or beyond, 6) Extranodal disease at the time of relapse, 7) Presence of B symptoms at the time of persistent disease upon completion of first-line chemotherapy, or of relapse, progressive disease, 8) Bulky disease (defined as any lesion greater than 5 cm) at the time of persistent disease upon completion of first-line chemotherapy, or of relapse, progressive disease.
  3. Adequate renal function, as defined by estimated serum creatinine clearance >/=50 ml/min (using the Cockcroft-Gault formula: creatinine clearance = [(140-age)*kg/(72*serum creatinine)] * 0.85 if female) 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, unless due to disease involvement
  5. Adequate pulmonary function with FEV1, FVC and DLCO >/=50% of expected corrected for hemoglobin and/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. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200329


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Yago Nieto, MD, PHD M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01200329    
Other Study ID Numbers: 2010-0142
NCI-2012-01885 ( Registry Identifier: NCI CTRP )
First Posted: September 13, 2010    Key Record Dates
Results First Posted: December 16, 2019
Last Update Posted: December 16, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Hodgkin's disease
Relapsed
Refractory
High-dose chemotherapy
Busulfan
Gemcitabine
Melphalan
Additional relevant MeSH terms:
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Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Melphalan
Busulfan
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists