Stem Cell Transplant for Non-Hodgkin's Lymphoma

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Disqualifiers: Pregnancy, HIV, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

18 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment for Non-Hodgkin's Lymphoma?

Research shows that autologous stem cell transplantation can lead to long-term survival and disease-free survival in patients with relapsed T-cell and B-cell non-Hodgkin's lymphoma. In one study, the 2-year disease-free survival was 28% for T-cell and 17% for B-cell patients, indicating that this treatment can be effective for some patients. ^{1 2 3 4 5}

Is stem cell transplantation generally safe for humans?

Stem cell transplantation, particularly autologous (using the patient's own cells), is considered relatively safe with advances in supportive care, showing a mortality rate mainly less than 5%. However, there is a risk of relapse after transplantation, and safety can vary depending on the patient's prior treatments and condition. ^{2 4 6 7 8}

How is autologous hematopoietic stem cell transplantation different from other treatments for non-Hodgkin's lymphoma?

Autologous hematopoietic stem cell transplantation is unique because it uses a patient's own stem cells to help recover from high-dose chemotherapy, which can be more effective than conventional chemotherapy for high-risk or relapsed non-Hodgkin's lymphoma. ^{1 4 9 10 11}

What is the purpose of this trial?

This is a research study testing a new approach to treating high-risk non-Hodgkin's lymphoma consisting of an autologous hematopoietic (blood) stem cell transplant (using a patient's own hematopoietic cells) followed by a non-myeloablative allogeneic transplantation (transplant from another individual). The investigators hypothesize that the addition of the second non-myeloablative transplant will improve the chances for long-term control of lymphoma.

Research Team

Keith Stockerl-Goldstein

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for adults aged 18-70 with high-risk non-Hodgkin's lymphoma who've had a stem cell transplant using their own cells. They must be in partial remission, have a matched donor ready, and agree to birth control. Excluded are those with prior radioimmunotherapy, progressive disease post-transplant, HIV-positive individuals or other recent cancers.

Inclusion Criteria

My blood counts are stable after a stem cell transplant, and I have a suitable donor.

Serum bilirubin < or = 2 x the institutional ULN

Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria

Pregnant or breast-feeding women

I have had cancer before, but I've been cancer-free for 5 years, except for certain skin cancers or in situ cervical cancer.

I have had a stem cell transplant more than 120 days ago or never had one.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Participants receive second-line chemotherapy for cytoreduction and to establish sensitivity to chemotherapy

6-9 weeks

Multiple visits for chemotherapy administration

Autologous Transplant

Participants undergo autologous hematopoietic stem cell transplant with high-dose chemotherapy

Approximately 60-120 days

Inpatient stay for transplant procedure

Allogeneic Transplant

Participants receive a non-myeloablative allogeneic transplant with total lymphoid irradiation and anti-thymocyte globulin

14 days

Inpatient stay for transplant procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Autologous Hematopoietic Stem Cell Transplantation
• Non-myeloablative Allogeneic Transplantation

Trial Overview The study tests if adding a second stem cell transplant from another person after an initial self-donated transplant can better control lymphoma. It involves drugs like Anti-thymocyte globulin and Tacrolimus to help the body accept the new cells.

Participant Groups

Group I: Allogeneic Transplant Experimental Treatment 6 Interventions

* TLI - 80 cGy on days -14, -11, -10, -9, -8, -7, -4, -3, -2, -1 * Anti-thymocyte globulin (ATG) 1.5 mg/kg on days -11, -10, -8, -7 * Solumedrol - 1 mg/kg on days -11, -10, -9, -8, -7 * Tacrolimus - beginning on day -3 with starting dose of 0.3 mg/kg PO BID. Will be continued per institutional guidelines. * Stem cell infusion - day 0 * Mycophenolate mofetil (MMF) - beginning on day 0 with dose of 15 mg/kg PO (5-10 hours after transplant)

Autologous Hematopoietic Stem Cell Transplantation is already approved in United States, European Union for the following indications:

Approved in United States as Autologous Hematopoietic Stem Cell Transplantation for:

• Various hematologic malignancies including non-Hodgkin lymphoma, multiple myeloma, and leukemia

Approved in European Union as Autologous Stem Cell Transplant for:

• Non-Hodgkin lymphoma
• Multiple myeloma
• Leukemia
• Other hematologic malignancies

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparison of high-dose therapy and autologous bone marrow transplantation for T-cell and B-cell non-Hodgkin's lymphomas. [2021]

2. Denmark pubmed.ncbi.nlm.nih.gov

[Autologous stem cell transplantation. From bone marrow to selected blood stem cells: 100 consecutive procedures at a single center]. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

Autologous bone marrow transplantation in non-Hodgkin's lymphoma: monoclonal antibodies plus complement for ex vivo marrow treatment. [2019]

4. Mexico pubmed.ncbi.nlm.nih.gov

[Comparison of the effectiveness of hematopoietic cell mobilization with chemotherapy and filgrastim versus filgrastim alone for autologous transplant in patients with lymphoma.] [2018]

5. England pubmed.ncbi.nlm.nih.gov

Treatment of poor prognosis non-Hodgkin's lymphoma using cyclophosphamide and total body irradiation regimens with autologous bone marrow rescue. [2013]

6. Croatia pubmed.ncbi.nlm.nih.gov

[Autologous hematopoietic stem cell transplantation]. [2009]

7. United States pubmed.ncbi.nlm.nih.gov

Trends in use of and survival after autologous hematopoietic cell transplantation in North America, 1995-2005: significant improvement in survival for lymphoma and myeloma during a period of increasing recipient age. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Nonmyeloablative allogeneic hematopoietic transplantation: a promising salvage therapy for patients with non-Hodgkin's lymphoma whose disease has failed a prior autologous transplantation. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Bone marrow transplantation for lymphoma CR1. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Long-Term Outcomes and Safety Trends of Autologous Stem-Cell Transplantation in Non-Hodgkin Lymphoma: A Report From A Tertiary Care Center in India. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Allogeneic haemopoietic stem cell transplantation for non-Hodgkin's lymphoma. [2019]