Clinical trial · Interventional

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

NCT00238433CI-TRIAL-00029674completedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Lymphoma	Lymphoma	ONTOLOGY_EXACT	0.90

Interventions

Interventions (6)

Intervention	Type	Mapped drug	Match
bone marrow ablation with stem cell support	Procedure	—	UNRESOLVED
busulfan	Drug	Busulfan	ALIAS
filgrastim	Biological	Filgrastim	ALIAS
melphalan	Drug	Melphalan	ALIAS
peripheral blood stem cell transplantation	Procedure	—	UNRESOLVED
thiotepa	Drug	Thiotepa	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Filgrastim/Melphalan/Thiotepa
description
Biological/Vaccine: filgrastim 5mcg/kg intravenous piggyback (IVPB) will be administered beginning on day +5 and continued until absolute neutrophil count (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/Surgery: 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/Surgery: peripheral blood stem cell transplantation Performed 36-48 hours following last chemotherapy dose.
interventionNames
1. Biological: filgrastim
2. Drug: busulfan
3. Drug: melphalan
4. Drug: thiotepa
5. Procedure: bone marrow ablation with stem cell support
6. Procedure: peripheral blood stem cell transplantation

Primary outcomes (2)

measure
Disease-Free Survival

Eligibility

Eligibility (as posted)

Sex: All
Maximum age: 70 Years

Show eligibility criteria text

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
        * Eastern Cooperative Oncology Group (ECOG) score 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 hematopoietic progenitor cell antigen (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)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 times ULN

Renal

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

Pulmonary

* No significant pulmonary dysfunction, defined as Diffusing Capacity the Lung for Carbon monoxide (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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment