Non Hodgkin Lymphoma Clinical Trial

Autologous and Allogeneic Transplant for Relapsed Lymphoma

Summary

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).

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Full Description

Lymphomas are the third most common group of cancers in children and adolescents in the United States. While Hodgkin's Disease (HD) has been described for many years, some subtypes of the non-Hodgkin's Lymphomas (NHL) have only recently been described. Non-Hodgkin's lymphomas traditionally have been classified as low, intermediate or high grade based on their clinical aggressiveness. More recently they have been divided into two major subgroups indolent and aggressive lymphomas by the current National Cancer Institute (NCI/PDQ) reference. Among children, aggressive histologies are prevalent including small non-cleaved cell lymphoma, lymphoblastic lymphoma, and diffuse large cell lymphoma. The most common histologic classifications of childhood non-Hodgkin's lymphoma over the past 30 years has included the morphological schema developed by Rappaport, the morphologically and immunologically based schema of Lukes and Collins, the Kiel classifications, the prognostic sub-groupings of the National Cancer Institute's Working Formulation, and the most recently developed classification that utilizes morphological, immunophenotypic and genetic information in the Revised European-American Lymphoma (REAL) classification.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patient must have adequate organ function as below

Adequate renal function defined as:

Serum creatinine less than or equal to 2.0 x normal, or
Creatinine clearance or radioisotope glomerular filtration rate (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
Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase (AST)) or serum glutamic-pyruvic transaminase (SPGT) (alanine aminotransferase (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:

Diffusing capacity of the lungs for carbon monoxide (DLCO) >50% by pulmonary function test for autologous transplant
DLCO > 40% by pulmonary function 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 positron emission tomography (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 initial 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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT00802113

Recruitment Status:

Completed

Sponsor:

Columbia University

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There are 6 Locations for this study

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Children's Memorial Hospital in Chicago
Chicago Illinois, 60611, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Columbia University Medical Center
New York New York, 10032, United States
New York Medical College
Valhalla New York, 10595, United States
Duke University
Durham North Carolina, 27708, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT00802113

Recruitment Status:

Completed

Sponsor:


Columbia University

How clear is this clinincal trial information?

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