Phase 2 N=37 Treatment

Busulfan, Melphalan, and Thiotepa in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Hodgkin's or Non-Hodgkin's Lymphoma

Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT00238433 ↗

Enrolled (actual)

Serious AEs

100.0%

Results posted

May 2017

Primary outcome: Primary: Disease-Free Survival — 34; 30; 28; 25 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: filgrastim (Biological); busulfan (Drug); melphalan (Drug); thiotepa (Drug); bone marrow ablation with stem cell support (Procedure); peripheral blood stem cell transplantation (Procedure)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: OHSU Knight Cancer Institute
Primary completion: Aug 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Disease-Free Survival	34; 30; 28; 25; 24; 22	—
PRIMARY Therapy-Related Toxicities	3; 26; 1; 33; 3; 2	—

Summary

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.

Eligibility 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
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00238433). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.