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S0410 Tandem Stem Cell Transplantation in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00233987
Recruitment Status : Completed
First Posted : October 6, 2005
Results First Posted : February 5, 2013
Last Update Posted : March 1, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with a peripheral stem cell transplant may allow more chemotherapy to be given so that more cancer cells are killed. Tandem (two) autologous stem cell transplants may be an effective treatment for Hodgkin's lymphoma.

PURPOSE: This phase II trial is studying how well tandem stem cell transplantation works in treating patients with progressive or recurrent Hodgkin's lymphoma.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: carmustine Drug: cyclophosphamide Drug: etoposide Drug: melphalan Procedure: autologous-autologous tandem hematopoietic stem cell transplantation Radiation: radiation therapy Phase 2

Detailed Description:


  • Determine the 2-year progression-free survival of patients with progressive or recurrent Hodgkin's lymphoma treated with tandem autologous stem cell transplantation (2 courses of high-dose therapy with autologous stem cell rescue).
  • Determine the response rate in patients treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

  • Salvage therapy (for patients with relapsed disease after achieving a previous complete response): Patients receive at least 2 courses of salvage chemotherapy or radiotherapy. No more than 6 weeks later, patients proceed to autologous hematopoietic stem cell collection.
  • Autologous hematopoietic stem cell collection: Patients undergo autologous hematopoietic stem cell collection. Patients with an inadequate number of collected stem cells are removed from the study.
  • Pre-transplant salvage radiation: Patients with residual tumor greater than 5 cm after initial salvage therapy undergo involved-field radiotherapy. All patients then proceed to the first preparative regimen.
  • First preparative regimen: Patients receive high-dose melphalan IV on day -1.
  • First autologous stem cell transplantation (SCT): Patients undergo autologous SCT on day 0. At least 28 days later, patients proceed to second preparative regimen.
  • Second preparative regimen: Patients receive 1 of the following preparative regimens:

    • Total-body irradiation (TBI)-based regimen: Patients undergo TBI twice daily on days -8 to -5. Patients also receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 1 hour on day -2.
    • Carmustine-based regimen: Patients receive carmustine IV over 2 hours on days -6 to -4, etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 1 hour on day -2.
  • Second autologous SCT: Patients undergo second autologous SCT on day 0. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 7 years.

PROJECTED ACCRUAL: A total of 85 patients will be accrued for this study over 2 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Recurrent Hodgkin's Disease (A BMT Study), Phase II
Study Start Date : October 2005
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: High-dose therapy plus tandem transplant
Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million cluster of differentiation 34 positive (CD34+) cells. Cycle 2 consists of either TBI-based or 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU)-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
Drug: carmustine
150 mg/m^2 IV over 2 hours 4, 5, and 6 days before transplant.
Other Name: BCNU

Drug: cyclophosphamide
100 mg/kg IV 2 days before transplant.

Drug: etoposide
60 mg/kg IV over 4 hours 4 days before transplant.

Drug: melphalan
150 mg/m^2 IV 1 day before transplant.

Procedure: autologous-autologous tandem hematopoietic stem cell transplantation
2.0 x 10^6 CD34+ cells, beginning at least 24 hours after melphalan infusion.

Radiation: radiation therapy
150 centigray (cGy) total body irradiation given b.i.d on days 5-8 before transplant.
Other Name: Total body irradiation (TBI)

Primary Outcome Measures :
  1. 2-year Progression-free Survival [ Time Frame: At day 60, then every 6 months for 2 years ]
    Measured from date of randomization to date of first observation of progressive disease, or death due to any cause

Secondary Outcome Measures :
  1. Response Rate [ Time Frame: At day 60, then every 6 months for 2 years ]
    Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.

  2. Overall Survival [ Time Frame: At day 60, then every 6 months for 2 years, then annually for a total of 7 years ]
    Measured from date of registration to date of death due to any cause or last contact

  3. Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug [ Time Frame: Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion ]
    Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed Hodgkin's lymphoma

    • Relapsed or refractory disease
    • Biopsy or radiological evidence of disease at time of recurrence/progression required
  • Has received ≥ 1 prior systemic chemotherapy regimen
  • No clonal abnormalities in marrow collection
  • Must undergo involved-field radiotherapy if bulky disease > 5 cm
  • Must have adequate sections of original diagnostic specimen available for review

    • Needle aspirations or cytologies are not adequate
  • No prior lymphoma, myelodysplastic syndromes, or leukemia (even if disease free > 5 years)
  • Patients who relapse after achieving a complete remission must complete a minimum of 2 courses of salvage chemotherapy or radiation therapy to determine if sensitive or resistant recurrent disease is present
  • No central nervous system (CNS) involvement



  • 15 to 70

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified


  • Absolute neutrophil count ≥ 1,500/mm^3


  • Bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless due to Hodgkin's disease)


  • Creatinine clearance ≥ 60 mL/min
  • Creatinine ≤ 2 times upper limit of normal


  • None of the following conditions requiring therapy:

    • Coronary artery disease
    • Cardiomyopathy
    • Congestive heart failure
    • Arrhythmias
  • Ejection fraction ≥ 45% by Multi Gated Acquisition Scan (MUGA) or 2-D echocardiogram


  • Adequate pulmonary function
  • Corrected diffusing capacity of lung for carbon monoxide (DLCO) ≥ 60% OR
  • Forced Expiratory Volume in One Side (FEV_1) ≥ 60% of predicted


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer
  • No known HIV or AIDS infection
  • No active bacterial, fungal, or viral infection
  • No medical condition that would preclude study treatment


Biologic therapy

  • Not specified


  • See Disease Characteristics

Endocrine therapy

  • Not specified


  • See Disease Characteristics


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00233987

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Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
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Study Chair: Eileen P. Smith, MD City of Hope Comprehensive Cancer Center
Study Chair: Patrick J. Stiff, MD Loyola University
Study Chair: Louis S. Constine, MD James P. Wilmot Cancer Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00233987    
Other Study ID Numbers: CDR0000442392
U10CA032102 ( U.S. NIH Grant/Contract )
S0410 ( Other Identifier: SWOG )
First Posted: October 6, 2005    Key Record Dates
Results First Posted: February 5, 2013
Last Update Posted: March 1, 2018
Last Verified: January 2018
Keywords provided by Southwest Oncology Group:
recurrent adult Hodgkin lymphoma
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors