Allogeneic Blood Stem Cell Transplantation and Adoptive Immunotherapy for Hodgkin's Disease - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00385788

Purpose

Primary Objectives:

To determine the efficacy of employing reduced-intensity allogeneic stem cell transplantation followed by adoptive immunotherapy in the form of early immunosuppression withdrawal to maximize a graft-vs-Hodgkin effect in patients with relapsed/refractory Hodgkin's disease (HD).
To assess the feasibility and efficacy of incorporating a program of scheduled donor leukocyte infusions (DLIs) in patients with recurrent and persistent or progressive disease after transplantation.
To evaluate the feasibility of incorporating gemcitabine, a highly active agent in HD, in the preparative regimen.

Condition	Intervention	Phase
Hodgkin's Disease	Drug: Gemcitabine Drug: Fludarabine Drug: Melphalan	Phase II

MedlinePlus related topics: Cancer Hodgkin's Disease

Drug Information available for: Fludarabine Fludarabine monophosphate Gemcitabine Gemcitabine hydrochloride Melphalan Sarcolysin Melphalan hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Allogeneic Stem Cell Transplantation Followed By Adoptive Immunotherapy for Patients With Relapsed and Refractory Hodgkin's Disease

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

Primary Outcome Measures:

To learn if fludarabine and melphalan followed by transplantation of stem cells as well as immune cells, collected from a mismatched relative, a matched unrelated donor, or an umbilical cord, can help to control Hodgkin's disease. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To study the safety of the treatment. [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	July 2005
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Gemcitabine + Fludarabine + Melphalan	Drug: Gemcitabine 800 mg/m^2 IV Over 30 Minutes x 1 Day Drug: Fludarabine 33 mg/m^2 IV Over 30 Minutes x 4 Days Drug: Melphalan 70 mg/m^2 IV Over 30 Minutes x 2 Days

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Eligibility

Ages Eligible for Study:	up to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients < 65 years of age with histologically confirmed refractory or relapsed Hodgkin's disease (including patients who fail or relapse after autologous SCT). In the event of transplants from unrelated donors, the upper age limit will be 50 years. Patients should have any of the following disease status: a. responsive or stable disease on salvage chemotherapy or radiation therapy. b. untreated, smoldering (i.e. not rapidly progressive) relapses.
Patients must have a serum bilirubin equal to or <2.0 mg/dl (isolated hyperbilirubinemia related to Gilbert's disease allowed), serum transaminase (ALT) equal to or < 3 times the upper limit of the normal range, serum creatinine equal to or <2.0 mg/dl, no symptomatic cardiac or pulmonary disease and a performance status equal to or <2. Left ventricular ejection fraction > or equal to 40%, FEV1, FVC and DLCO > or equal to 50% predicted .
Patients must have an HLA-compatible related or unrelated donor (one-antigen mismatched related donors are acceptable) willing to donate marrow or rhG-CSF-mobilized peripheral blood stem cells. In the event of transplants from matched unrelated donors, a high-resolution allele match for HLA-A, -B,
C, -DRB1 and DQB1 ("10 of 10 match") is preferred. However, a one-antigen mismatch is also considered "acceptable matching" ("9 of 10 match"). HLA-compatible cord blood units will also be acceptable for recipient with an actual body weight of up to 60 kg.
Women of childbearing potential must have a negative serum pregnancy test within two weeks of study entry and should be advised to avoid becoming pregnant. Men should be advised to not father a child while on treatment. Both women of childbearing potential and men must agree to practice effective methods of contraception.
Patients must be capable and willing to sign informed consent.

Exclusion Criteria:

Patients with documented disease progression on salvage chemotherapy.
Nursing or pregnant females. Should a woman become pregnant or suspect she is pregnant while participating in the study, she should inform her treating physician immediately.
Severe concomitant medical or psychiatric illness.
Uncontrolled arrhythmia or symptomatic cardiac or pulmonary disease.
Chronic active hepatitis or cirrhosis.
Active or uncontrolled infection.
Radiation therapy within 2 months of transplant admission.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00385788

Contacts

Contact: Paolo Anderlini, MD

713-792-8750

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Paolo Anderlini, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Paolo Anderlini, MD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Paolo Anderlini, MD/Associate Professor )
Study ID Numbers:	2005-0015
Study First Received:	October 9, 2006
Last Updated:	October 31, 2008
ClinicalTrials.gov Identifier:	NCT00385788 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Hodgkin's Disease
Stem Cell Transplantation
Antithymocyte Globulin
Gemcitabine

Gemzar
Fludarabine
Fludarabine Phosphate
Melphalan

Study placed in the following topic categories:

Antimetabolites
Melphalan
Immunoproliferative Disorders
Immunologic Factors
Hodgkin Lymphoma, Adult
Hodgkin's Disease
Fludarabine monophosphate
Antiviral Agents
Immunosuppressive Agents
Antilymphocyte Serum

Lymphatic Diseases
Radiation-Sensitizing Agents
Antineoplastic Agents, Alkylating
Fludarabine
Lymphoproliferative Disorders
Gemcitabine
Alkylating Agents
Hodgkin Disease
Lymphoma

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Melphalan
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Therapeutic Uses
Gemcitabine
Lymphoma
Hodgkin Disease
Alkylating Agents
Immunoproliferative Disorders

Neoplasms by Histologic Type
Immune System Diseases
Enzyme Inhibitors
Fludarabine monophosphate
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Radiation-Sensitizing Agents
Myeloablative Agonists
Fludarabine
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on May 06, 2009