Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 3 evaluate procarbazine hydrochloride, primarily focusing on central nervous system tumors, Hodgkin lymphoma, non-Hodgkin lymphoma, and primary CNS lymphoma. Sponsored by academic centers and cooperative groups, these protocols assess procarbazine within combination chemo-immunotherapy or response-adapted regimens for newly diagnosed and relapsed or refractory conditions. Across these investigations, recruitment statuses encompass completed, actively recruiting, active not recruiting, terminated, and withdrawn trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05675410 RECRUITING
Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8
National Cancer Institute (NCI)
 2023-05-11 PHASE3
NCT00887146 ACTIVE_NOT_RECRUITING
Brain and Central Nervous System Tumors
Alliance for Clinical Trials in Oncology
 2009-09 PHASE3
NCT06830421 RECRUITING
Primary Central Nervous System Lymphoma
University Hospital Freiburg
 2023-08-09 PHASE3
NCT06541665 ACTIVE_NOT_RECRUITING
Primary Central Nervous System Lymphoma
Ono Pharmaceutical Co., Ltd.
 2024-05-17 PHASE1
NCT07015242 RECRUITING
Lymphoma
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
 2025-11-06 PHASE2
NCT02315326 COMPLETED
Adult Patients With Newly Diagnosed or Relapsed or Refractory Primary Central Nervous System Lymphoma (PCNSL); Or Relapsed or Refractory Secondary Central Nervous System Lymphoma (SCNSL)
Memorial Sloan Kettering Cancer Center
 2014-12-08 PHASE1; PHASE2
NCT03495960 COMPLETED
Primary Central Nervous System Lymphoma
International Extranodal Lymphoma Study Group (IELSG)
 2019-06-15 PHASE2
NCT03576378 UNKNOWN
Hodgkin Lymphoma
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
 2018-08-08 PHASE1; PHASE2
NCT05008224 COMPLETED
Classical Hodgkin Lymphoma
Merck Sharp & Dohme LLC
 2021-10-07 PHASE2
NCT05425654 UNKNOWN
Primary CNS Lymphoma
National Research Center for Hematology, Russia
 2021-05-17 PHASE2
NCT00596154 COMPLETED
CNS Lymphoma; CNS Brain Cancer; Non-Hodgkin's Lymphoma
Memorial Sloan Kettering Cancer Center
 2004-12 PHASE2
NCT02661503 UNKNOWN
Classical Hodgkin Lymphoma
University of Cologne
 2016-07 PHASE3
NCT00574496 COMPLETED
Lymphoma
Memorial Sloan Kettering Cancer Center
 2007-11-13 PHASE2
NCT01775475 COMPLETED
AIDS-related Diffuse Large Cell Lymphoma; AIDS-related Diffuse Mixed Cell Lymphoma; AIDS-related Diffuse Small Cleaved Cell Lymphoma; AIDS-related Immunoblastic Large Cell Lymphoma; AIDS-related Lymphoblastic Lymphoma; AIDS-related Peripheral/Systemic Lymphoma; AIDS-related Small Noncleaved Cell Lymphoma; Stage III AIDS-related Lymphoma; Stage IV AIDS-related Lymphoma
AIDS Malignancy Consortium
 2016-09-15 PHASE2
NCT02298283 COMPLETED
Hodgkin Lymphoma
The Lymphoma Academic Research Organisation
 2015-04 PHASE2
NCT01356680 COMPLETED
Hodgkin Lymphoma
University of Cologne
 2012-01-13 PHASE3
NCT01399372 COMPLETED
Chemotherapeutic Agent Toxicity; Cognitive/Functional Effects; Lymphoma; Neurotoxicity; Radiation Toxicity
Radiation Therapy Oncology Group
 2011-09 PHASE2
NCT02800447 UNKNOWN
Advanced Hodgkin's Lymphoma
Lee's Pharmaceutical Limited
 2016-06
NCT02333513 UNKNOWN
Recurrent High-grade Glioma
Hebei Yanda Hospital
 2015-02
NCT00577993 COMPLETED
Lymphoma
M.D. Anderson Cancer Center
 1998-03-16 PHASE3
NCT00822120 COMPLETED
Lymphoma; Nonneoplastic Condition
SWOG Cancer Research Network
 2009-07 PHASE2
NCT00594815 COMPLETED
Lymphoma
Memorial Sloan Kettering Cancer Center
 2002-08-28
NCT01132807 COMPLETED
Lymphoma
Alliance for Clinical Trials in Oncology
 2010-05 PHASE2
NCT00678327 COMPLETED
Lymphoma
University College, London
 2008-08-29 PHASE3
NCT00335140 TERMINATED
Lymphoma
Eastern Cooperative Oncology Group
 2007-08-23 PHASE2
NCT01390584 TERMINATED
Lymphoma
ECOG-ACRIN Cancer Research Group
 2013-05-24 PHASE2
NCT01569204 COMPLETED
Hodgkin Lymphoma
University of Cologne
 2012-10 PHASE2
NCT01737346 UNKNOWN
Recurrent Glioblastoma Multiforme
Incheon St.Mary's Hospital
 2012-10 PHASE2
NCT00433459 COMPLETED
Lymphoma
Christine Mauz-Körholz
 2007-01 PHASE3
NCT01124240 UNKNOWN
Newly Diagnosed Non Methylated Glioblastoma Multiforme Grade 4
Northern Sydney and Central Coast Area Health Service
 2009-11 PHASE2
NCT00666484 COMPLETED
Lymphoma; Neurotoxicity
University College, London
 2008-03 PHASE2
NCT01468740 UNKNOWN
HIV-associated Hodgkin Lymphoma
Harlachinger Krebshilfe e.V.
 2004-03 PHASE2
NCT00989352 UNKNOWN
Primary Non Hodgkin Lymphoma of the Central Nervous System
University Hospital Freiburg
 2009-09 PHASE2
NCT00079105 COMPLETED
Lymphoma
Newcastle-upon-Tyne Hospitals NHS Trust
 2004-01 PHASE2
NCT00503594 UNKNOWN
Lymphoma
Assistance Publique - Hôpitaux de Paris
 2007-07 PHASE2
NCT00049595 COMPLETED
Lymphoma
European Organisation for Research and Treatment of Cancer - EORTC
 2002-08 PHASE3
NCT01251107 COMPLETED
Hodgkin Lymphoma
Fondazione Michelangelo
 2000-03 PHASE3
NCT00002463 COMPLETED
Brain and Central Nervous System Tumors
M.D. Anderson Cancer Center
 1989-02 PHASE2
NCT00187057 COMPLETED
Ataxia-Telangiectasia
St. Jude Children's Research Hospital
 2002-09
NCT00079092 COMPLETED
Brain and Central Nervous System Tumors
Wake Forest University Health Sciences
 2004-01-01 PHASE2
NCT00002944 COMPLETED
Brain Tumors; Central Nervous System Tumors
Children's Oncology Group
 1997-04 PHASE3
NCT00416832 COMPLETED
Lymphoma
Christine Mauz-Körholz
 2002-11 PHASE2
NCT00049439 COMPLETED
Lymphoma
Case Comprehensive Cancer Center
 1998-03 PHASE2
NCT00003375 COMPLETED
Brain and Central Nervous System Tumors
Radiation Therapy Oncology Group
 1998-10 PHASE2; PHASE3
NCT00002569 COMPLETED
Brain and Central Nervous System Tumors
Radiation Therapy Oncology Group
 1994-07 PHASE3
NCT00004010 COMPLETED
Lymphoma
Children's Oncology Group
 1999-10 PHASE2
NCT00005796 COMPLETED
Bone Marrow Suppression; Brain and Central Nervous System Tumors; Drug/Agent Toxicity by Tissue/Organ
Indiana University
 2000-02 PHASE1
NCT00002806 COMPLETED
Brain and Central Nervous System Tumors
Alliance for Clinical Trials in Oncology
 1996-07 PHASE2
NCT00264953 COMPLETED
Hodgkin´s Lymphoma
University of Cologne
 1998-05 PHASE3
NCT00003113 TERMINATED
Lymphoma
Case Comprehensive Cancer Center
 1997-07 PHASE2
NCT00003114 COMPLETED
Lymphoma
Case Comprehensive Cancer Center
 1997-07 PHASE2
NCT00002840 COMPLETED
Brain and Central Nervous System Tumors
European Organisation for Research and Treatment of Cancer - EORTC
 1996-08 PHASE3
NCT00003101 COMPLETED
Brain and Central Nervous System Tumors
Memorial Sloan Kettering Cancer Center
 1997-08 PHASE2
NCT00003293 COMPLETED
Brain and Central Nervous System Tumors
Pfizer
 1998-02 PHASE3
NCT00074191 COMPLETED
Lymphoma
OHSU Knight Cancer Institute
 2000-01 PHASE2
NCT00002462 ACTIVE_NOT_RECRUITING
Lymphoma
European Organisation for Research and Treatment of Cancer - EORTC
 1989-09 PHASE3
NCT00003929 WITHDRAWN
Lymphoma
Case Comprehensive Cancer Center
 1998-06 PHASE2
NCT00379041 ACTIVE_NOT_RECRUITING
Lymphoma
European Organisation for Research and Treatment of Cancer - EORTC
 1993-09-01 PHASE3
NCT00003564 Withdrawn
Brain and Central Nervous System Tumors
M.D. Anderson Cancer Center|National Cancer Institute (NCI)
 Phase 3
NCT00003788 UNKNOWN
Brain and Central Nervous System Tumors
Colorado Health Foundation
 1998-04 PHASE3
NCT00003564 WITHDRAWN
Brain and Central Nervous System Tumors
M.D. Anderson Cancer Center
 PHASE3
NCT00416377 UNKNOWN
Lymphoma
Children's Cancer and Leukaemia Group
NCT00004004 COMPLETED
Brain and Central Nervous System Tumors
New Approaches to Brain Tumor Therapy Consortium
 1999-07 PHASE1; PHASE2
NCT00734773 WITHDRAWN
Brain and Central Nervous System Tumors; Lymphoma; Neurotoxicity
Northwestern University
 2008-11 EARLY_PHASE1
NCT00417014 UNKNOWN
Lymphoma
Children's Cancer and Leukaemia Group
NCT00052455 COMPLETED
Brain and Central Nervous System Tumors
Institute of Cancer Research, United Kingdom
 2002-10 PHASE3
NCT00265031 COMPLETED
Hodgkin´s Lymphoma
University of Cologne
 1999-01 PHASE3
NCT00003421 COMPLETED
Lymphoma
Medical Research Council
 1998-06 PHASE3
NCT00025064 UNKNOWN
Lymphoma
Children's Cancer and Leukaemia Group
 2000-01 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-09-04)

Check the Procarbazine HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a polyfunctional alkylating agent, procarbazine interferes with cellular machinery across multiple metabolic pathways, thereby blocking DNA and protein synthesis and arresting cells midway through mitosis. This cytostatic inhibition of cell division halts malignant cell proliferation, providing therapeutic efficacy in clinical trial settings for patients with Hodgkin lymphoma and central nervous system malignancies.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.