Phase 2
Completed N=50
Study of Melphalan HCl for Injection (Propylene Glycol-free), Carmustine, Etoposide, Cytarabine (BEAM Regimen) and Autologous Stem Cell Transplantation for Lymphoma
Hodgkin Disease · Lymphoma, Non-Hodgkin
Source: ClinicalTrials.gov NCT01969435 ↗
Enrolled (actual)
50
Serious AEs
2.0%
Results posted
Nov 2016
Primary outcomePrimary: Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events — 34; 6; 7; 3 participants
Summary
Phase II study is being conducted to confirm the safety and efficacy of high-dose Melphalan HCl for Injection (Propylene Glycol-Free) when included in the BEAM regimen for myeloablative conditioning in lymphoma patients undergoing ASCT
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events |
34; 6; 7; 3; 5; 7 | — |
| PRIMARY Treatment-related Mortality (TRM) |
— | — |
| SECONDARY Efficacy as Measured by Response Rates |
84; 4; 0; 12 | — |
| SECONDARY Disease-free Survival |
64 | — |
| SECONDARY Disease-free Survival |
64 | — |
| SECONDARY Time to Engraftment (Neutrophil) |
10 | — |
| SECONDARY Time to Engraftment (Platelet) |
19 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Hodgkin lymphoma or non-Hodgkin lymphoma.
- Eligible for autologous stem cell transplantation.
- 18 to 75 years of age at time of enrollment.
- Adequate autologous graft, defined as an unmanipulated, cryopreserved, peripheral blood stem cell graft containing at least 2 x 10^6 CD34+ cells/kg based on patient body weight
- ECOG performance status ≤ 2
- Normal organ function as defined below:
- Creatinine clearance > 40 ml/min
- Total bilirubin ≤2.0 x IULN
- AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
- LVEF > 40% (by ECHO or MUGA)
- FEV1 > 50% of predicted and DLCO > or = 50% of predicted
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Able to understand and willing to sign an IRB approved written informed consent document.
Exclusion Criteria
- A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
- Currently receiving any other experimental therapy or has received any other experimental therapy within the 4 weeks prior to enrollment.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to melphalan HCl for injection (propylene glycol-free), Captisol, or other agents used in the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmias, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant and/or breastfeeding women. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry.
- Known HIV-positivity. These patients are excluded because of the potential for pharmacokinetic interactions with the study regimen and their antiretroviral therapy and because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. .
Data sourced from ClinicalTrials.gov (NCT01969435). 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. Informational only — not medical advice.