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Autologous and Allogeneic Transplant for Relapsed Lymphoma

This study is currently recruiting participants.
Verified January 2012 by Columbia University
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT00802113
First received: May 5, 2008
Last updated: January 18, 2012
Last verified: January 2012
History of Changes
  Purpose

The sequential combination of myeloablative therapy and autologous stem cell transplantation (APBSCT) followed by a reduced intensity allogeneic stem cell transplant (Allo SCT) and post SCT adoptive cellular immunotherapy will be well tolerated in patients with refractory or recurrent non-Hodgkin's lymphoma (NHL) and Hodgkin's disease (HD).


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Hodgkins Disease
 Drug: Fludarabine and Busulfan
Drug: Fludarabine, Busulfan and ATG
 Phase 1
Phase 2

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: Sequential Myeloablative Stem Cell Transplantation and Reduced Intensity Allogeneic Stem Cell Transplantation in Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma and Hodgkin's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • To study the feasibility of administering sequential myeloablative APBSCT followed by reduced intensity Allo SCT in patients with refractory/recurrent NHL and HD. [ Time Frame: Until end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the toxicity associated with sequential myeloablative APBSCT followed by reduced intensity Allo SCT in patients with refractory/recurrent NHL and HD [ Time Frame: Until end of study ] [ Designated as safety issue: Yes ]
  • To determine the response rates in those with measurable disease of sequential myeloablative APBSCT followed by reduced intensity Allo SCT in patients with refractory/recurrent NHL and HD [ Time Frame: Until end of study ] [ Designated as safety issue: No ]
  • To determine the overall and progressive free survival of sequential myeloablative APBSCT followed by reduced intensity AlloSCT in patients with refractory/recurrent NHL and HD. [ Time Frame: Until end of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2001
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Fludarabine and Busulfan
Fludarabine 30 mg/m2 x 5 days Busulfan 3.2 mg/kg/day x 2 days GVHD Prophylaxis with MMF and FK506
Other Names:
  • Fludara
  • Busulfex
Experimental: B Drug: Fludarabine, Busulfan and ATG
Fludarabine 30 mg/m2 x 5 days Busulfan 3.2 mg/kg/day x 2 days Anti-Thymocyte Globulin 2.0 mg/kg/day x 4 days GVHD Prophylaxis with MMF and FK506
Other Names:
  • Fludara
  • Busulfex
  • ATG

  Eligibility

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must have adequate organ function as below

Adequate renal function defined as:

Serum creatinine 2.0 x normal, or Creatinine clearance or radioisotope GFR > 40 ml/min/m2 or >60 ml/min/1.73 m2 or an equivalent GFR as determined by the institutional normal range

Adequate liver function defined as:

Total bilirubin <2.0 x normal; or SGOT (AST) or SGPT (ALT) <5.0 x normal

Adequate cardiac function defined as:

Shortening fraction of >27% by echocardiogram, or Ejection fraction of >47% by radionuclide angiogram or echocardiogram

Adequate pulmonary function defined as:

DLCO >50% by pulmonary function test for autologous transplant DLCO > 40% by pulmonary fuction test for reduced intensity allogeneic transplant For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry >94% in room air.

Disease Status (Eligibility)

- Patients with Non-Hodgkin's Lymphoma with either of the following: Primary induction failure* (failure to achieve initial CR) who have a partial response (PR) or stable disease (SD) with reinduction chemotherapy. *All patients are required to have a biopsy regardless of PET/Gallium results.

Patients with 1st PR, 2nd CR, 2nd PR, or 2nd SD following reinduction chemotherapy Patients with 3rd CR, 3rd PR, 3rd SD following reinduction chemotherapy - Patients with Hodgkin's Disease with either of the following: Primary induction failure (failure to achieve initial CR) and/or primary refractory disease.

First relapse Early relapse (within 12 months off therapy) (excluding those who received no therapy or radiation therapy only for intial therapy) Late relapse (greater than 12 months off therapy). Only patients with recurrent Stage III or IV disease and/or those with B symptoms at relapse (all other late relapses are excluded).

Second relapse. Third relapse.

- Patients must achieve a CR, PR or SD after reinduction chemotherapy.

Exclusion Criteria:

  • Patients with NHL or HD with 4th or greater CR, PR, and/or SD
  • Patients with progressive disease (PD) unresponsive to reinduction chemo, radio, or immunotherapy
  • Hodgkin's Disease in late relapse (other than those discussed above).
  • Patients with post-transplant lymphoproliferative disease following a solid organ transplantation or AIDS associated NHL .
  • Patients who don't have an eligible donor
  • Women who are pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00802113

Contacts
Contact: Prakash Satwani, MD 212-305-0223 ps2087@columbia.edu
Contact: Kristen Petrillo, RN 212-305-2050 kp2254@columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Duke University
Investigators
Principal Investigator: Prakash Satwani, MD Columbia University
  More Information

No publications provided

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00802113     History of Changes
Other Study ID Numbers: AAAA5185, CHNY-01-501
Study First Received: May 5, 2008
Last Updated: January 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Autologous Stem Cell Transplant
Cord Blood Transplant
Allogeneic Stem Cell Transplant
Relapsed Lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Busulfan
Fludarabine monophosphate
Fludarabine
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on May 23, 2013