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Busulfan, Melphalan, and Thiotepa in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Hodgkin's or Non-Hodgkin's Lymphoma
This study has been completed.
Study NCT00238433   Information provided by OHSU Knight Cancer Institute

First Received on October 12, 2005.   Last Updated on April 10, 2012   History of Changes

October 12, 2005
April 10, 2012
March 2005
March 2012   (final data collection date for primary outcome measure)
  • Disease-free survival at 3, 6, 9, 12, 18, and 24 months post transplantation [ Time Frame: 3, 6, 9, 12, 18, and 24 months post transplantation ] [ Designated as safety issue: No ]
  • Regimen-related toxicity through 24 months post transplantation [ Time Frame: Through 24 months post transplantation ] [ Designated as safety issue: Yes ]
  • Disease-free survival at 3, 6, 9, 12, 18, and 24 months post transplantation
  • Regimen-related toxicity through 24 months post transplantation
Complete list of historical versions of study NCT00238433 on ClinicalTrials.gov Archive Site
 
  • Quality of life (QOL) as measured by Grant Ferrell 1994 QOL Scale-Bone Marrow Transplant prior to transplantation, at days 30 and 100 post transplantation
  • Assessment of the relationship between caregiving QOL and patient QOL as measured by Grant Ferrell 1994 Family QOL Scale at days 30 and 100 post transplantation
 
 
 
Busulfan, Melphalan, and Thiotepa in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Hodgkin's or Non-Hodgkin's Lymphoma
A Phase II Study to Evaluate the Safety and Efficacy of IV Busulfan, Melphalan, and Thiotepa (BuMelTT) Followed By Autologous PBSC Infusion for Patients With Hodgkin's Disease and Non-Hodgkin's Lymphoma

RATIONALE: Chemotherapy, such as busulfan, melphalan, and thiotepa, may destroy cancerous blood-forming cells (stem cells) in the blood and bone marrow. Giving the patient their healthy stem cells will help their bone marrow make new stem cells that become red blood cells, white blood cells, and platelets.

PURPOSE: This phase II trial is studying how well busulfan, melphalan, and thiotepa work in treating patients who are undergoing an autologous stem cell transplant for Hodgkin's or non-Hodgkin's lymphoma.

OBJECTIVES:

  • Determine the therapeutic efficacy of a myeloablative preparative regimen comprising busulfan, melphalan, and thiotepa followed by autologous peripheral blood stem cell (PBSC) transplantation in patients with Hodgkin's or non-Hodgkin's lymphoma.
  • Determine the toxic effects of this preparative regimen in these patients.

OUTLINE:

  • Myeloablative preparative regimen: Patients receive busulfan IV over 3 hours on days -8 to -6, melphalan IV over 15-30 minutes on days -5 and -4, and thiotepa IV over 2 hours on days -3 and -2.
  • Peripheral blood stem cell (PBSC) transplantation: Patients undergo PBSC transplantation on day 0 followed by filgrastim (G-CSF) IV over 30 minutes beginning on day 5 and continuing until blood counts recover.
  • Intrathecal chemotherapy: Patients with a history of treated CNS disease or at high-risk for CNS relapse receive methotrexate and cytarabine intrathecally (IT) for 2 doses each within 10 days prior to transplantation and 4-6 doses each beginning on day 32 post-transplantation.
  • Consolidation therapy: Patients with residual bulk disease at 80-100 days post-transplantation that is > 2.5 cm by CT scan may undergo local radiotherapy to residual scar/disease provided it can be encompassed in a single radiation port and the volume of lung to be irradiated is ≤ 20%.

After completion of study treatment, patients are followed weekly for 1 month, monthly for 6 months, every 3 months for 6 months, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
  • Biological: filgrastim
    5mcg/kg IVPB will be administered beginning on day +5 and continued until ANC> 1500 for 2 consecutive days.
  • Drug: busulfan
    3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.
  • Drug: melphalan
    50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.
  • Drug: thiotepa
    250 mg/m2/day/iv on days -3 and -2
  • Procedure: bone marrow ablation with stem cell support
    The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.
  • Procedure: peripheral blood stem cell transplantation
    Performed 36-48 hours following last chemotherapy dose.
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
 
March 2012   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following:

    • Intermediate- or high-grade non-Hodgkin's lymphoma (NHL), meeting 1 of the following criteria:

      • In first complete remission (CR) AND at high-risk for relapse, as defined by all of the following criteria:

        • High age-adjusted International Prognostic Index category AND meets the following criteria at diagnosis:

          • Stage III or IV disease
          • Lactic dehydrogenase abnormal
          • ECOG 0-2
        • Mantle cell histology
      • Primary refractory disease
      • Beyond first CR
    • Low-grade NHL

      • Beyond second relapse
    • Hodgkin's lymphoma

      • Primary refractory disease OR beyond first CR
  • Must have an adequate number of stored autologous peripheral blood stem cells (PBSCs) (i.e., 2.0 x 10^6 CD34-positive cells/kg)

    • Patients who are not able to mobilize a sufficient number of PBSCs may use bone marrow instead
  • No active CNS disease NOTE: 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

  • 0 to 70

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Bilirubin < 2 times upper limit of normal (ULN)
  • AST and ALT < 3 times ULN

Renal

  • Creatinine ≤ 2.0 mg/dL
  • Creatinine clearance ≥ 50 mL/min

Pulmonary

  • No significant pulmonary dysfunction, defined as DLCO < 60% of predicted

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception for ≥ 2 months before and during study participation
  • HIV negative
  • No significant active infection that would preclude PBSC transplantation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior transplantation
  • No other concurrent blood products during PBSC transplantation

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • More than 60 days since prior local or regional radiotherapy

Surgery

  • Not specified

Other

  • More than 30 days since prior investigational drugs
  • No concurrent amphotericin
Both
up to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00238433
CDR0000446086, P30CA069533, OHSU-HEM-04083-L, OHSU-IRB-248
 
OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Study Chair: Richard Maziarz, MD OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP