Clinical trial NCT01969435: Study of Melphalan HCl for Injection (Propylene Glycol-free), Carmustine, Etoposide, Cytarabine (BEAM Regimen) and Autologous Stem Cell Transplantation for Lymphoma
Official title: A Phase II Study of Melphalan HCl for Injection (Propylene Glycol-free), Combined With Carmustine, Etoposide, and Cytarabine (BEAM Regimen) for Myeloablative Conditioning in Lymphoma Patients Undergoing Autologous Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hodgkin Disease
Lymphoma, Non-Hodgkin
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2013-10-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


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. .

Primary outcomes:
measure: Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
timeFrame: Day -7 through Day 30
measure: Treatment-related Mortality (TRM)
timeFrame: 100 days
Secondary outcomes:
measure: Efficacy as Measured by Response Rates
timeFrame: Up to Day 100
measure: Disease-free Survival
timeFrame: 1 year
measure: Disease-free Survival
timeFrame: 2 years
measure: Time to Engraftment (Neutrophil)
timeFrame: Assessed up to day 30
measure: Time to Engraftment (Platelet)
timeFrame: Assessed up to day 100
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Amanda Cashen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: