NCT00345865

Autologous Peripheral Stem Cell Transplant in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma

Completed Phase 2 Results posted Last updated 14 July 2020

What this trial tests

Phase 2 trial testing carmustine in Lymphoma in 473 participants. Completed in 28 June 2019.

Timeline

24 August 2005

Primary endpoint
28 June 2019

28 June 2019

Quick facts

Lead sponsor	Masonic Cancer Center, University of Minnesota
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	473
Start date	24 August 2005
Primary completion	28 June 2019
Estimated completion	28 June 2019
Sites	1 location across United States

Drugs / interventions tested

• carmustine (CARMUSTINE) — full drug profile →
• cyclophosphamide (cyclophosphamide) — full drug profile →
• etoposide (etoposide) — full drug profile →
• peripheral blood stem cell transplantation
• irradiation therapy
• G-CSF
• Cytarabine — full drug profile →

Conditions studied

• Lymphoma — all drugs for Lymphoma →

Sponsor

Masonic Cancer Center, University of Minnesota

Who can join

Under 75, any sex, with Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With 1 Year Progression Free Survival Primary · 1 year

Progression is defined using the Response Criteria for Non-Hodgkin's Lymphoma given by NCI Sponsored International Working Group.The definition is as follows: At least a 50% increase from nadir of any previously identified abnormal node. Appearance of any new lesion during or at the end of therapy.

Group	Value	95% CI
NHL With Irradiation	112
HL Without Irradiation	102
NHL - HIV Infected With Irradiation	1
NHL - HIV Infected Without Irradiation	2
NHL Without Radiation and Cyclophosphamide	116

Number of Participants With 2 Years Progression Free Survival Primary · 2 years

Progression is determined using Response Criteria for Non-Hodgkin's Lymphoma given by NCI Sponsored International Working Group. Definition is as follows: At least a 50% increase from nadir of any previously identified abnormal node. Appearance of any new lesion during or at the end of therapy.

Group	Value	95% CI
NHL With Irradiation	96
HL Without Irradiation	91
NHL - HIV Infected With Irradiation	1
NHL - HIV Infected Without Irradiation	1
NHL Without Radiation and Cyclophosphamide	106

Number of Participants With 1 Year Overall Survival Primary · 1 year

Group	Value	95% CI
NHL With Irradiation	139
HL Without Irradiation	144
NHL - HIV Infected With Irradiation	1
NHL - HIV Infected Without Irradiation	5
NHL Without Radiation and Cyclophosphamide	128

Number of Participants With 2 Years Overall Survival Primary · 2 years

Group	Value	95% CI
NHL With Irradiation	124
HL Without Irradiation	140
NHL - HIV Infected With Irradiation	1
NHL - HIV Infected Without Irradiation	4
NHL Without Radiation and Cyclophosphamide	121

Number of Participants With Hematopoietic Recovery After Transplantation Secondary · Day 42

return to ANC (absolute neutrophil count) more than 500 cells/milliliter.

Group	Value	95% CI
NHL With Irradiation	171
HL Without Irradiation	147
NHL - HIV Infected With Irradiation	2
NHL - HIV Infected Without Irradiation	5
NHL Without Radiation and Cyclophosphamide	145

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

NHL With Irradiation

Serious: 34/171 (20%)

Deaths: 47/171

HL Without Irradiation

Serious: 18/149 (12%)

Deaths: 9/149

NHL - HIV Infected With Irradiation

Serious: 1/2 (50%)

Deaths: 1/2

NHL - HIV Infected Without Irradiation

Serious: 1/5 (20%)

Deaths: 1/5

NHL Without Radiation and Cyclophosphamide

Serious: 0/146 (0%)

Deaths: 25/146

Serious adverse events (9 terms)

Reaction	System	NHL With Irradiation	HL Without Irradiation	NHL - HIV Infected With Ir…	NHL - HIV Infected Without…	NHL Without Radiation and …
Relapse	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Disease progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Death due to relapse	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Death	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Death due to progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Hemorrhage	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Pulmonary failure	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Myelodysplasia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Death due to multi organ failure	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—

Other adverse events (13 terms — click to expand)

Reaction	System	NHL With Irradiation	HL Without Irradiation	NHL - HIV Infected With Ir…	NHL - HIV Infected Without…	NHL Without Radiation and …
Infection	Infections and infestations	—	—	—	—	—
Pneumonia	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Neuropathy	Nervous system disorders	—	—	—	—	—
Other Kidney disorder	Renal and urinary disorders	—	—	—	—	—
Decreased heart function	Cardiac disorders	—	—	—	—	—
sensory loss	Nervous system disorders	—	—	—	—	—
Deep vein thrombosis	Vascular disorders	—	—	—	—	—
GI bleeding	Gastrointestinal disorders	—	—	—	—	—
Thrombosis	Vascular disorders	—	—	—	—	—
hypothyroidism	Endocrine disorders	—	—	—	—	—
Intubation	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
deconditioning	Metabolism and nutrition disorders	—	—	—	—	—
Surgery	Injury, poisoning and procedural complications	—	—	—	—	—

Most-reported serious reactions: Relapse, Disease progression, Death due to relapse, Death, Death due to progression, Hemorrhage, Pulmonary failure, Myelodysplasia.

Data from ClinicalTrials.gov NCT00345865 adverse events section.

Sponsor's own description

RATIONALE: Drugs used in chemotherapy, such as ifosfamide, etoposide, and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored for peripheral stem cell transplant. Giving more chemotherapy, such as cyclophosphamide, carmustine, and etoposide, and total-body irradiation prepares the patient's bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. More radiation therapy is given after transplant to kill any remaining cancer cells.

PURPOSE: This phase II trial is studying how well autologous peripheral stem cell transplant works in treating patients with non-Hodgkin's lymphoma or Hodgkin's lymphoma.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. AIDS-Related Non-Hodgkin's Lymphoma in the Era of Highly Active Antiretroviral Therapy.
   Vishnu P, Aboulafia DM. · · 2012 · cited 18× · PMID 22400030 · DOI 10.1155/2012/485943
2. Positron Emission Tomography-Based Assessment of Metabolic Tumor Volume Predicts Survival after Autologous Hematopoietic Cell Transplantation for Hodgkin Lymphoma.
   Procházka V, Gawande RS, Cayci Z, Froelich JW, et al · · 2018 · cited 14× · PMID 28942016 · DOI 10.1016/j.bbmt.2017.09.006
3. Cytochrome P450 2B6*5 Increases Relapse after Cyclophosphamide-Containing Conditioning and Autologous Transplantation for Lymphoma.
   Bachanova V, Shanley R, Malik F, Chauhan L, et al · · 2015 · cited 11× · PMID 25677220 · DOI 10.1016/j.bbmt.2015.02.001