Auto Stem Cell Transplant for Lymphoma Patients

NCT03125642 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2016LS132MT2016-11C
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II study of autologous transplant for patients with Hodgkin (HL) and non-Hodgkin lymphomas (NHL) including those who are HIV positive.

Conditions

Non-Hodgkin Lymphoma; Hodgkin Lymphoma

Keywords

Lymphoblastic Lymphoma; Mature B-cell Lymphomas; Follicular Lymphoma; Diffuse Large B-Cell Lymphoma; Mantle Cell Lymphoma; Burkitt's/Burkitt's like; Mature T-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival Comparison

  Compare progression-free survival (PFS) at 3 years post-transplant for patients who received who received a radiation free preparative regimen to the prior study MT2004-24 where NHL subjects received total body irradiation (TBI) as part of their preparative regimen.

  3 years post transplant

Secondary Outcomes (6)

• Overall Survival

  3 years post transplant

• Treatment related mortality

  6 months post transplant

• Treatment related mortality

  1 year post transplant

• Secondary malignancies

  3 years post transplant

• Neutrophil engraftment

  Day +1 to engraftment

Study Arms (3)

BEAM: NHL & HL

EXPERIMENTAL

BCNU, etoposide, Ara-C and melphalan (BEAM) for all NHL and those HL patients who are unable to receive CBV

Drug: Etoposide; Drug: BCNU; Drug: AraC; Drug: Melphalan; Procedure: Peripheral blood stem cell transplantation; Biological: G-CSF

CBV: HL

EXPERIMENTAL

Cyclophosphamide, BCNU and VP-16 (CBV) for HL patients

Drug: Etoposide; Drug: BCNU; Drug: Cyclophosphamide

CY/TBI

EXPERIMENTAL

Cyclophosphamide/Total Body Irradiation (CY/TBI) for patients with recent history of CNS lymphoma or those with allergies/contra-indications to agents used in BEAM

Procedure: Peripheral blood stem cell transplantation; Biological: G-CSF; Drug: Cyclophosphamide; Radiation: Total Body Irradiation

Interventions

Etoposide DRUG

BEAM: 100 mg/m\^2 IV over 2 hours BID on Days -5, -4, -3, -2 \| CBV: 150 mg/m\^2 intravenously over 4 hours every 12 hours starting at 6 a.m. and 6 p.m. on Days -6, -5, -4

Also known as: VP-16

BEAM: NHL & HL; CBV: HL

BCNU DRUG

BEAM \& CBV: 300 mg/m\^2 IV over over 2 hours on Day -6

Also known as: Carmustine

BEAM: NHL & HL; CBV: HL

AraC DRUG

BEAM: 100 mg/m\^2 IV over 1 hour BID on Days -5, -4, -3, -2

Also known as: Cytarabine, cytosine arabinoside, Cytosar-U, Depocyt

BEAM: NHL & HL

Melphalan DRUG

BEAM: 140 mg/m\^2 IV over 20 minutes on Day -1

Also known as: Alkeran

BEAM: NHL & HL

Peripheral blood stem cell transplantation PROCEDURE

All Arms: Day 0 infuse PBSC. All patients will have PBSC collected by leukapheresis. Mobilization will be done with G-CSF.

Also known as: PBSC

BEAM: NHL & HL; CY/TBI

G-CSF BIOLOGICAL

All patients should receive G-CSF, 5 ug/kg/day IV as a bolus injection each evening beginning on day +5 until the ANC is \>2500 x 10\^9/L for 2 consecutive days. G-CSF will subsequently be restarted at 5 ug/kg/day SC or IV if the ANC falls below 1000/mm\^3

Also known as: filgrastim

BEAM: NHL & HL; CY/TBI

Cyclophosphamide DRUG

CBV: 1.5 gm/M\^2 over 2 hours at 10 a.m. on Days -6, -5, -4, -3 \| CY/TBI: 60 mg/kg IV over 2 hours on Days -7, -6

Also known as: Cytoxan

CBV: HL; CY/TBI

Total Body Irradiation RADIATION

CY/TBI: 165 cGy bid on Day -4, -3, -2, -1

Also known as: TBI

CY/TBI

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible Diseases
• Non-Hodgkin's Lymphoma (NHL)
• Patients with chemo-sensitive histologically confirmed NHL will be eligible for this treatment protocol contingent on histologic sub-classification.
• Patients in partial or complete remission following cell therapy will also be eligible.
• NHL patients with resistant or refractory lymphoma (no PR following up to three cycles of combination chemotherapy) will not be eligible for transplant in this trial.
• Lymphoblastic Lymphoma:
• All patients will be eligible in second or greater complete remission (CR) or first or subsequent partial remission (PR)
• Patients with any high-risk features will be eligible in first complete remission
• High risk features include: Stage IV, LDH \>2 x upper limit of normal, ≥ 2 extranodal sites
• Mature B-cell Lymphoma
• Follicular Lymphoma and other indolent lymphoma in ≥ second CR2/PR2
• Diffuse Large B-Cell Lymphoma: in ≥ CR2 or ≥ PR1; a high intermediate or high IPI (≥ 2 for age-adjusted IPI or ≥3 for IPI) at diagnosis and double-hit or triple-hit lymphoma will be eligible in first CR; transformed lymphoma from FL (or other indolent lymphoma) or chronic lymphocytic leukemia will be eligible if chemosensitive and bone marrow is negative
• Mantle Cell Lymphoma: in first or greater CR or PR
• Burkitt's/Burkitt's like: all patients except localized lymphoma will be eligible any time after initial therapy (after achievement of first complete remission), or in partial remission if they fail to achieve CR; patients with localized (stage I or Ziegler stage A) will be eligible only if they fail to achieve CR1 or after relapse
• Mature T-Cell Lymphoma

You may not qualify if:

• Pregnant or breastfeeding: Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy
• Eligible for any higher priority transplant protocols
• Chemotherapy resistant disease
• Unrelated active infection

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Hodgkin Disease; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Mantle-Cell; Lymphoma, T-Cell

Interventions

Etoposide; Carmustine; Cytarabine; Melphalan; Peripheral Blood Stem Cell Transplantation; Granulocyte Colony-Stimulating Factor; Filgrastim; Cyclophosphamide; Whole-Body Irradiation

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Lymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Nitrosourea Compounds; Urea; Amides; Nitroso Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Proteins; Biological Factors; Phosphoramide Mustards; Phosphoramides; Organophosphorus Compounds; Radiotherapy; Investigative Techniques

Study Officials

• Veronika Bachanova, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy Krepski

CONTACT

612-273-2800; tkrepsk1@fairview.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 24, 2017
• Study Start: April 20, 2017
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: November 4, 2025

Record last verified: 2025-10

Locations

US (1)