Skip to main content
OpenTrials
Completed

NCT Number: NCT00802113

Autologous and Allogeneic Transplant for Relapsed Lymphoma

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

Up to 55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Children's Memorial Hospital in Chicago, Chicago, Illinois, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fludarabine

Drug

Fludarabine 30 mg/m2 x 5 days

Other names: Fludara

busulfan

Drug

Busulfan 3.2 mg/kg/day x 2 days

Other names: Busulfex

anti-thymocyte globulin

Drug

Anti-Thymocyte Globulin 2.0 mg/kg/day x 4 days

Other names: ATG

Primary outcomes

  1. Total Number of Subjects With a Complete Response (CR) Following Myeloablative Conditioning (MAC) and Autologous Stem Cell Transplantation (AutoSCT)

    Time frame: Up to 1 year post-transplantation

    Complete Response is defined as the complete resolution of B symptoms (i.e., weight loss, night sweats and fever) and normalization of all sites of disease on the basis of physical exam, bone marrow biopsy, and imaging studies.

  2. Total Number of Subjects With a Disease Relapse or Progression Following MAC AutoSCT

    Time frame: Up to 1 year post-transplantation

    Includes subjects with any measurable growth of disease in a previously affected site or detection of disease in a new site confirmed by biopsy.

  3. Total Number of Subjects With Partial Response or Stable Disease Following MAC AutoSCT

    Time frame: Up to 1 year post-transplantation

    Total includes subjects with partial response and patients with stable disease, defined as <50% reduction in measurable disease or the uninterrupted persistence of B symptoms.

Secondary outcomes

  1. Time to Neutrophil Engraftment

    Time frame: Up to 1 year post-transplantation

    Following MAC AutoSCT, the median time to neutrophil (PMN) recovery will be measured.

  2. Time to Platelet Engraftment

    Time frame: Up to 1 year post-transplantation

    Following MAC AutoSCT, the median time to platelet recovery will be measured.

  3. Total Number of Subjects With Grade II-IV Acute Graft-versus-Host-Disease (GVHD)

    Time frame: Up to 1 year post-transplantation

    The criteria for grading is based on extent of organ involvement (i.e., Skin, Liver and Gut - rash on >50% of skin, bilirubin 2-3 mg/dl, diarrhea > 500 ml/day) with Grade II being better outcome and Grade IV being worse outcome.

  4. Total Number of Subjects That Experienced Transplant-related Mortality (TRM)

    Time frame: Up to 1 year post-transplantation

    Status as subjects died post-AlloHCT

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2014
Study completion
2014
First posted
Dec 4, 2008
Registry last updated
Mar 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.