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A Prospective, Comparative Trial of Allogeneic Versus Autologous Stem Cell Transplantation for High Risk Lymphoma


Phase 2
15 Years
55 Years
Not Enrolling
Both
Lymphoma

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Trial Information

A Prospective, Comparative Trial of Allogeneic Versus Autologous Stem Cell Transplantation for High Risk Lymphoma


OBJECTIVES: I. Compare the relapse rate, progression free survival, and overall survival in
patients with high risk non-Hodgkin's lymphoma or Hodgkin's disease treated with allogeneic
vs autologous stem cell transplantation. II. Compare the toxicities (short and long term) of
these 2 regimens in these patients.

OUTLINE: Cytoreductive therapy: Patients receive 3 courses of salvage chemotherapy (e.g.,
dexamethasone, high dose cytarabine, and cisplatin (DHAP); etoposide, methylprednisolone,
high dose cytarabine, and cisplatin (ESHAP); fludarabine, mitoxantrone, and dexamethasone
(FND)). Harvest: Patients with an HLA identical sibling donor are assigned to the allogeneic
peripheral blood stem cell (PBSC) transplantation group. Patients without an HLA identical
sibling are assigned to the autologous PBSC transplantation group. Allogeneic OR autologous
PBSC are harvested. Conditioning regimen: Patients receive high dose chemotherapy comprised
of cyclophosphamide IV over 1 hour on days -6 to -3 and carmustine IV over 3 hours and
etoposide IV over 3 hours on days -6 to -4. PBSC are infused on day 0. Patients are followed
weekly for 3 months, then monthly for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study over 4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven non-Hodgkin's lymphoma that has relapsed or
failed to achieve complete remission after first line induction chemotherapy Intermediate
or high grade (including mantle cell, but excluding lymphoblastic disease) No more than 1
prior salvage chemotherapy regimen, e.g.: Dexamethasone, high dose cytarabine, and
cisplatin (DHAP) Etoposide, methylprednisolone, high dose cytarabine, and cisplatin
(ESHAP) Low grade No more than 2 prior salvage chemotherapy regimens, e.g.: Fludarabine,
mitoxantrone, and dexamethasone (FND) ESHAP DHAP OR Histologically proven stage III or IV
Hodgkin's disease that has relapsed or failed to achieve remission after combination
induction chemotherapy Prior primary radiotherapy allowed if relapse is high risk (e.g.,
recurrence in radiation field, B symptoms, liver/marrow involvement) No more than 2 prior
salvage chemotherapy regimens Allogeneic stem cell transplantation group: Availability of
6 antigen (A, B, and DR loci) HLA matched sibling donor No active CNS disease A new
classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The
terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of
"low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former
terminology.

PATIENT CHARACTERISTICS: Age: 15 to 55 Performance status: ECOG 0 or 1 Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL
SGOT and SGPT no greater than 3 times normal PT and PTT normal Renal: Creatinine no
greater than 2.0 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: LVEF at
least 45% by MUGA scan or echocardiogram No myocardial infarction within the past 6 months
No arrhythmias unless medically controlled Pulmonary: FEV1 at least 50% predicted DLCO at
least 50% predicted Other: No diabetes mellitus or thyroid disease unless medically
controlled No active serious infection HIV negative Not pregnant or nursing Negative
pregnancy test

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

relapse rate

Outcome Description:

determine relapse rate after allogeneic versus autologous hematopoietic progenitor cell transplantation

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Steven C. Goldstein, MD

Investigator Role:

Study Chair

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Federal Government

Study ID:

11306

NCT ID:

NCT00005613

Start Date:

March 1996

Completion Date:

June 2010

Related Keywords:

  • Lymphoma
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Florida Cancer SpecialistsFort Myers, Florida  33901