Phase 2 N=25 Treatment

Combination Chemotherapy Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or High-Risk Primary Refractory Hodgkin Lymphoma

Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT00574496 ↗

Enrolled (actual)

Serious AEs

25.0%

Results posted

Sep 2023

Primary outcome: Primary: Progression-free Survival at 1 Year — 33.3 proportion of progression-free pts

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: cyclophosphamide (Drug); cyclosporine (Drug); fludarabine phosphate (Drug); gemcitabine hydrochloride (Drug); ifosfamide (Drug); mechlorethamine hydrochloride (Drug); melphalan (Drug); methotrexate (Drug); mycophenolate mofetil (Drug); prednisone (Drug); procarbazine hydrochloride (Drug); vincristine sulfate (Drug); vinorelbine tartrate (Drug); allogeneic bone marrow transplantation (Procedure); allogeneic hematopoietic stem cell transplantation (Procedure); nonmyeloablative allogeneic hematopoietic stem cell transplantation (Procedure); peripheral blood stem cell transplantation (Procedure); umbilical cord blood transplantation (Procedure); total-body irradiation (Radiation)
Age: Pediatric, Adult, Older Adult · 13+ yrs
Sex: All
Sponsor: Memorial Sloan Kettering Cancer Center
Primary completion: Aug 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Progression-free Survival at 1 Year	33.3	—
SECONDARY Overall Survival	70.3	—
SECONDARY Disease Relapse or Progression as Measured by CT Scan or PET	34.3	—

Summary

RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine, mycophenolate mofetil, and methotrexate before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well combination chemotherapy followed by donor stem cell transplant works in treating patients with relapsed or high-risk primary refractory Hodgkin lymphoma.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed classical Hodgkin lymphoma, including CD20+ disease
No lymphocyte predominant histology
Primary refractory or relapsed disease with all 3 risk factors, failed platinum-based chemotherapy, or disease relapsed more than 100 days after autologous stem cell transplantation, proven by biopsy or fine-needle aspiration (cytology) of an involved site
Risk factors are defined as B-symptoms, extranodal sites of disease, and disease remission lasting 50,000/mm^3
ANC > 1,000/mm^3
Cardiac ejection fraction > 50% (for patients ≥ 18 years of age)
Fractional shortening > 50% by echocardiogram* (for patients 50% on pulmonary function testing*
Serum creatinine < 1.5 mg/dL
Creatinine clearance ≥ 50 mL/min
Total bilirubin < 2.0 mg/dL in the absence of a history of Gilbert disease
HIV I and II negative
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Karnofsky performance status (PS) ≥ 70% or Lansky PS ≥ 70% (for patients proceed to AHSCT)
No active and uncontrolled infection at time of transplantation including active infection with Aspergillus or other mold (for patients proceed to AHSCT) NOTE: *measured since last chemotherapy

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior allogeneic transplantation
No more than 1 prior autologous transplantation
No inability to complete planned cytoreduction due to therapy complications

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00574496). 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.