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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


Phase 2
N/A
70 Years
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival at 3, 6, 9, 12, 18, and 24 months post transplantation

Outcome Time Frame:

3, 6, 9, 12, 18, and 24 months post transplantation

Safety Issue:

No

Principal Investigator

Richard Maziarz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

CDR0000446086

NCT ID:

NCT00238433

Start Date:

March 2005

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • recurrent grade 3 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage IV adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV adult Burkitt lymphoma
  • recurrent mantle cell lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • recurrent marginal zone lymphoma
  • splenic marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent/refractory childhood Hodgkin lymphoma
  • stage III childhood Hodgkin lymphoma
  • stage IV childhood Hodgkin lymphoma
  • recurrent childhood anaplastic large cell lymphoma
  • stage III childhood anaplastic large cell lymphoma
  • stage IV childhood anaplastic large cell lymphoma
  • childhood grade III lymphomatoid granulomatosis
  • recurrent childhood large cell lymphoma
  • stage III childhood large cell lymphoma
  • stage IV childhood large cell lymphoma
  • recurrent childhood lymphoblastic lymphoma
  • stage III childhood lymphoblastic lymphoma
  • stage IV childhood lymphoblastic lymphoma
  • recurrent childhood small noncleaved cell lymphoma
  • stage III childhood small noncleaved cell lymphoma
  • stage IV childhood small noncleaved cell lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • stage III cutaneous T-cell non-Hodgkin lymphoma
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Knight Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97239-3098