Clinical trial NCT00901225: Study of Plerixafor for Rescue of Poor Mobilizers in Autologous Stem Cell Transplant
Official title: Plerixafor Rescue Mobilization For Autologous Stem Cell Transplant Patients With Inadequate Response to G-CSF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Non-Hodgkins Lymphoma
Hodgkins Disease
Keywords: NHL
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
First posted: 2009-05-13
Enrollment: 21
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: Plerixafor, administered at a dose of 240 ug/kg, potentiates the effect of granulocyte colony-stimulating factor (G-CSF) to increase peripheral blood progenitor cells in both healthy volunteers and cancer patients. Furthermore, in cancer patients, cells collected via apheresis using Plerixafor and G-CSF have been successfully transplanted. In December 2008, Plerixafor received approval from the Food and Drug administration for use in combination with G-CSF to aid in mobilization of progenitor cells for apheresis. The proposed study is not designed to support approval of a new indication or change in the advertising for Plerixafor. The route of administration and dosage level are identical to that which is listed on the package insert. Although Plerixafor is not approved for patients with Hodgkins Lymphoma, there is no known or theoretic increased risk of the use of this drug in this patient population.

The study hypothesis for this study is that patients with a circulating CD34+ count \< 20 cells/ul after 5 days of mobilization with G-CSF alone will achieve \> or equal to 2 X 10(6)CD34+ cells/kg within 3 days of apheresis after receiving Plerixafor with G-CSF.

Detailed description: This is a single-center, Phase 2, open-label study. All patients diagnosed with non-hodgkins lymphoma, hodgkins disease or multiple myeloma and candidates for autologous transplantation are eligible to enter into the study. The only change to the standard of care is the addition of 240 ug/kg Plerixafor following 5 days of (G-CSF) mobilization.

The results of the study will provide both numeric and categorical estimates of measurements of the safety and efficacy of Plerixafor. The primary efficacy endpoint, Treatment Success, is a binary response variable categorizing whether the patient was able to mobilize at least 2 X 10(6) CD34+ cells/kg within 3 days of apheresis.

The percentage of patients achieving Treatment Success will be summarized. All AEs will be followed for 30 days after the last apheresis or until the first dose of ablative chemotherapy, whichever occurs first. All SAEs will be followed for 6 months post-transplant or until relapse. All patients who receive at least one dose of Plerixafor will be included in all summaries of AEs.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 75 years.
* Diagnosis of NHL, HD or MM
* Eligible for autologous transplantation
* CD34+ cell count \< 7 cells/ul after 5 days of mobilization with G-CSF or CD34+ cell count between 7 and 19 (inclusive) on day 5 of mobilization with G-CSF and \< 1.3 x 106 CD34+ cells collected by apheresis on day 5 of G-CSF therapy.
* \< or equal to 5 prior regimens of chemotherapy (Rituxan is not considered chemotherapy for the purpose of this study)
* ≥ 3 weeks since last cycle of chemotherapy and the beginning of G-CSF mobilization (Rituxan and Lenalidomide are not considered chemotherapy for the purpose of this study)
* Total dose of melphalan \< or equal to 200 mg
* ECOG performance status of 0 or 1
* Recovered from all acute toxic effects of prior chemotherapy
* Absolute PMN count \> 1.0 X 10(9)/l prior to first dose of G-CSF
* PLT count \> 75 X 10(9)/l prior to first dose of G-CSF
* Serum creatinine \< or equal to 2.5 mg/dl
* SGOT, SGPT and total bilirubin \< 2 X upper limit of normal (ULN) prior to the first dose of G-CSF
* Cardiac and pulmonary status sufficient to undergo apheresis and transplantation as determined by standard institutional practice
* Signed informed consent
* Patients of childbearing potential agree to use an approved form of contraception

Exclusion Criteria:

* A co-morbid condition which, in the view of the investigator, renders the patient at high risk from treatment complications
* Failed previous stem cell collection or collection attempts
* A residual acute medical condition resulting from prior chemotherapy
* Active brain metastases or carcinomatous meningitis
* Active infection requiring antibiotic treatment (excluding controlled catheter-related bacteremia)
* Received prior radio-immunotherapy with Zevalin or Bexxar
* Received thalidomide, dexamethasone, and/or Velcade within 7 days prior to the first dose of G-CSF
* Positive pregnancy test in female patients
* Lactating females
* Patients who previously received experimental therapy within 4 weeks of enrolling in this protocol

Primary outcomes:
measure: Number of Participants Who Achieved > or Equal to 2 X 10(6)CD34+ Cells/kg Within 3 Days of Apheresis After Receiving Plerixafor With G-CSF.
timeFrame: 5 days after receiving G-CSF
Secondary outcomes:
measure: Number of Participants Experiencing a Grade III/IV Toxicity
timeFrame: 6 months post transplant or until relapse
measure: Number of Subjects Experiencing Graft Failure
timeFrame: 12 months
measure: Days to Absolute Neutrophil Count >500
timeFrame: 12 months
measure: Number of Subjects Experiencing Durability of Engraftment
timeFrame: 12 months
measure: Platelet Engraftment
timeFrame: 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Mitchell Horwitz, MD
role: PRINCIPAL_INVESTIGATOR
References: