NCT01511562|Active Not RecruitingPhase 2Results

Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma

A Randomized Phase II Trial of Myeloablative Versus Non-Myeloablative Consolidation Chemotherapy for Newly Diagnosed Primary CNS B-cell Lymphoma

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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3 other identifiers

CALGB-51101CDR0000721927NCI-2012-00110

Study Type

interventional

Target

113

Locations

1 country

Sites

126

Timeline

RegisteredJan 2012

StartedSep 2012

CompletionMay 2027

Brief Summary

The purpose of this study is to find out what effects (good and/or bad) treatment with chemotherapy and stem cell transplant compared with chemotherapy alone will have on primary CNS B-cell lymphoma. Currently the best treatment for patients with primary CNS B-cell lymphoma is not known.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

113

participants targeted

Target at P75+ for phase_2 lymphoma

Timeline

12mo left

Started Sep 2012

Longer than P75 for phase_2 lymphoma

Geographic Reach

1 country

126 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

14.7 years study duration

Study Progress93%

Sep 2012May 2027

First Submitted

Initial submission to the registry

January 13, 2012

Completed

5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2012

Completed

8 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed

8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2020

Completed

5.1 years until next milestone

Results Posted

Study results publicly available

January 14, 2026

Completed

1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2027

Expected

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

8.3 years

First QC Date

January 13, 2012

Results QC Date

December 23, 2025

Last Update Submit

January 14, 2026

Conditions

Lymphoma

Keywords

primary central nervous system non-Hodgkin lymphomacontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomastage I adult diffuse large cell lymphomastage III adult diffuse large cell lymphomastage IV adult diffuse large cell lymphoma

Outcome Measures

Primary Outcomes (1)

Progression Free Survival
The primary endpoint is to compare the two-year progression-free survival (PFS) of patients treated with the myeloablative consolidation treatment strategy of HDT/ASCT versus those treated with non-myeloablative consolidation chemotherapy with cytarabine and etoposide. PFS time = time from Registration to earliest date of Progression or Death due to any cause, censoring non-progressed and alive patients at the date of last disease status evaluation. Response will be defined using the modified IPCG criteria. Progressive disease is defined as \> 25% increase in contrast-enhancing CNS (brain and spine if latter abnormal at baseline) disease, appearance of any new, measurable (\>/= 10mm) contrast-enhancing disease or recurrent or new ocular or CSF disease.
2 years

Secondary Outcomes (3)

Event Free Survival
2 years
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
7 years
Overall Survival
2 years

Study Arms (2)

Arm I

OTHER

Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant.

Drug: carmustineDrug: thiotepaProcedure: stem cell transplantDrug: G-CSF

Arm II

OTHER

Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy.

Drug: cytarabineDrug: etoposideDrug: G-CSF

Interventions

cytarabineDRUG

Given IV

Arm II

etoposideDRUG

Given IV

Arm II

thiotepaDRUG

Given IV

Arm I

G-CSFDRUG

Arm IArm II

carmustineDRUG

Given IV

Arm I

stem cell transplantPROCEDURE

Arm I

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

1. Documentation of Disease: Diagnosis of primary CNS diffuse large B-cell lymphoma confirmed by one of the following: brain biopsy or resection, cerebrospinal fluid and vitreous fluid. 2. Other Lymphomas: Patients must have no evidence or history of non-Hodgkin lymphoma (NHL) outside of CNS. 3. Previous Treatment: Patients must have no prior chemotherapy or radiation therapy for lymphoma. 4. Age- Patients must be between the ages of 18 and 75 years. 5. Karnofsky Performance Scale - Patients must measure Karnofsky Performance Scale ≥ 30 (≥ 50 for patients ages 60-70). 6. Pregnancy and Nursing Status - Patients must be non-pregnant and non-nursing; women of childbearing potential must have a negative serum or urine pregnancy test 10-14 days prior to registration; in addition, women and men of childbearing potential must commit to use an effective form of contraception throughout their participation in this study; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom) 7. HIV - Patients must have negative HIV serology. 8. Hepatitis - Patients must have negative HCV serology (unless HBsAb positive patient has recently received HBV vaccine, in this case HBcAb should be negative). All patients must be screened for hepatitis B infection before starting treatment. Those patients who test positive for hepatitis B should be closely monitored for evidence of active HBV infection and hepatitis during and for several months after rituximab treatment. PCNSL patients with a history of hepatitis B infection should be treated with entecavir or lamivudine (physician discretion for choice of drug) as antiviral prophylaxis to prevent hepatitis B reactivation. 9. Organ Transplant or Immunosuppressant Therapy - Patient must have no history of organ transplantation or ongoing immunosuppressant therapy. 10. Required Initial Laboratory Values: ANC ≥ 1500/mcL, AST and ALT \< 2 x upper limit of normal (ULN), total bilirubin ≤ 3 mg/dL, creatinine clearance ≥ 50 mL/min, platelet count ≥ 100,000/mcL

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Alliance for Clinical Trials in Oncologylead
National Cancer Institute (NCI)collaborator

Study Sites (126)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

Location

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504, United States

Location

Alaska Breast Care and Surgery LLC