Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Gemcitabine

Etoposide

Vinorelbine

Cyclophosphamide

Etoposide phosphate

Carmustine

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antimetabolites

Enzyme Inhibitors

Tubulin Modulators

Antimitotic Agents

Gemcitabine and high-dose chemotherapy followed by peripheral blood stem cell (PBSC) rescue. Chemotherapy includes Gemcitabine + Vinorelbine + Carmustine + Etoposide + Cyclophosphamide.

Autologous HCT

Sally Arai, MD

This is a phase 2 study of gemcitabine + high-dose chemotherapy followed by peripheral blood stem cell (PBSC) rescue for Hodgkin's Disease

To assess the non-hematologic toxicity and determine the phase 2 dose of gemcitabine in combination with vinorelbine followed by carmustine, etoposide and cyclophosphamide and autologous hematopoietic stem cell transplantation \[aka peripheral blood stem cell (PBSC)\].

Gemcitabine and Hodgkin's Disease Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Hodgkin's Disease

Gemcitabine and High-dose Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Relapsed or Resistant Hodgkin's Disease

Reported as the number of Phase 1 participants by gemcitabine dose that experienced non-hematologic toxicity, ie, drug-related adverse events.

Pulmonary toxicity as assessed by the number of participants that experience BCNU pneumonitis, ie, pneumonitis due to carmustine (BCNU).

Reports the percentage of participants surviving 6 months after PBSC infusion (transplant).

Reports the percentage of participants that experienced relapse post-transplant.

Reports the survival measures:

* Freedom from progression (FFP)
* Event-free survival (EFS)
* Overall survival (OS)

EFS and OS were estimated by Kaplan-Meier method

Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

National Institutes of Health (NIH)

National Institute of Allergy and Infectious Diseases (NIAID)

Stanford University

Assistant Professor of Medicine

Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue \[aka, hematopoietic stem cell transplantation (AHCT)\].

Gemcitabine + High-dose Chemotherapy + PBSC Rescue

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Dr. Sally Arai

1250 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue

1500 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue

7 patients received 1 of 2 dose levels during the Phase 1 dose-escalation component of the study

Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity

Gemcitabine (1250 or 1500 mg/m2) administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue \[aka, hematopoietic stem cell transplantation (AHCT)\].

Patients who completed the study regardless of gemcitabine dose, and had all data points collected.

Pulmonary Toxicity (BCNU Pneumonitis)

Gemcitabine (1250 or 1500 mg/m2) as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue \[aka, hematopoietic stem cell transplantation (AHCT)\].

Overall Survival (OS)

Relapse Post-transplant

Freedom from Progression (FFP)

Event-Free Survival (EFS)

Gemcitabine 1250 mg/m2 administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue \[aka, hematopoietic stem cell transplantation (AHCT)\].

1250 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue

Lists the results as included in the publication, which included 92 participants who received the MTD treatment; completed the study; and had all data points collected

Spots Global Cancer Trial Database for Gemcitabine and Hodgkin's Disease Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Hodgkin's Disease

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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