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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)

NCT02570542

Active Not RecruitingPhase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Conditions: Diffuse Large B-cell Lymphoma (DLBCL), Relapsed Diffuse Large B-cell Lymphoma (DLBCL), Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Interventions: leukapheresis, Plerixafor, carmustine, etoposide, cytarabine, melphalan, Autologous Stem Cell Transplantation

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (14)

Omaha, Nebraska, United States
Basking Ridge, New Jersey, United States
Middletown, New Jersey, United States
Montvale, New Jersey, United States
Commack, New York, United States
Harrison, New York, United States
Manhasset, New York, United States
New York, New York, United States
New York, New York, United States
Rochester, New York, United States
Uniondale, New York, United States
Nashville, Tennessee, United States
San Antonio, Texas, United States
Milwaukee, Wisconsin, United States