Clinical trial NCT02570542: Study of the Impact of CD34+ Cell Dose on Absolute Lymphocyte Count Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Official title: A Multi-center Randomized Phase II Study of the Impact of CD34+ Cell Dose on Absolute Lymphocyte Count Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Diffuse Large B-cell Lymphoma (DLBCL)
Relapsed Diffuse Large B-cell Lymphoma (DLBCL)
Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Keywords: CD34+ Cell Dose
Autologous Stem Cell Transplantation
15-193
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Columbia University
name: Endeavor Health
name: University of Rochester
name: Medical College of Wisconsin
name: University of Nebraska
name: Sanofi
name: University Hospitals Seidman Cancer Center
First posted: 2015-10-07
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study the impact of stem cell dose on outcome after autologous transplant.

Detailed description: Following enrollment, patients will be CD34+ stem cell mobilized at the discretion of the treating attending physician with the plerixafor for the achievement of \>6 x10\^6 CD34+ cells/kg. The patients that fail to mobilize \>6 x10\^6 CD34+ cells/kg will not be randomized and will subsequently be followed for disease progression and overall survival.. Patients with \>6 x10\^6 CD34+ cells/kg cryopreserved on study will be admitted to the hospital for planned ASCT. Patients will be randomly infused with either 3-4 x 10\^6 CD34+ stem cells/kg or 6-8 x10\^6 CD34+ stem cells/kg on d0 per study randomization. The cell dose ranges within the two groups allows variability within aliquots of cells at the time of cryopreservation. Patients will receive standard supportive measures (including: growth factor support post-HDT/ASCT, antimicrobial prophylaxis, red blood cell and platelet transfusion and treatment for neutropenic fever) as per institutional guideline practices.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Diagnosed with relapsed or refractory de novo DLBCL or follicular lymphoma transformed to DLBCL to one previous line of anthracycline-containing chemotherapy
* KPS ≥ 70
* Complete or partial response by IWG Working Group or ICML Criteria to maximum of one salvage line of chemotherapy without pre-HDT/ASCT salvage radiotherapy.
* Eligible for high-dose therapy and autologous stem-cell rescue

  * Serum creatinine ≤ 1.5 mg/dL, or if creatinine \>1.5 mg/dL, calculated creatinine clearance of ≥50 mL/min by 24 hour creatinine clearance or CKD-EPI.
  * Last cycle of most recent salvage therapy within 8 weeks of enrollment
* Total bilirubin \< 2.0 mg/dL

  o If Gilbert"s disease is suspected and total bilirubin \> 2.0 mg/dL, direct bilirubin must be \< 2.0 mg/dL
* Females of childbearing potential and males must agree to use an acceptable form of contraception per institutional practices.

Exclusion Criteria:

* Disease progression by IWG Working Group or ICML Criteria since last therapy
* Prior autologous or allogeneic stem cell transplantation
* HIV infection
* Comorbid condition(s) which, in the opinion of the attending physician and/or MSKCC Principal Investigator, will preclude stem cell mobilization and/or high-dose therapy with autologous stem cell rescue
* Treatment plan that includes post-transplant maintenance therapy
* Salvage therapy that includes involved field radiotherapy

Primary outcomes:
measure: progression-free survival (PFS)
timeFrame: at +/- 2 weeks
Secondary outcomes:
measure: the impact of CD34+ cell dose on lymphocyte subset recovery
timeFrame: day 15
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up Only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent and Follow up Only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent and Follow Up Only)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Consent and Follow-up Only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: Manhasset
country: United States
facility: Northwell Health (Data collection only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Consent and Follow up Only)
state: New York
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: San Antonio
country: United States
facility: Texas Transplant Institute
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Sergio Giralt, MD
role: PRINCIPAL_INVESTIGATOR
References: