Lymphoma, B-cellPhase 2NCT00482053
Phase 2 Poor Risk DLBCL of TLI and ATG Followed by Matched Allogeneic HT as Consolidation to Autologous HCT
A Phase 2 study testing Autologous hematopoietic stem cell transplantation (auto-HSCT), Allogeneic hematopoietic stem cell transplantation (allo-HSCT) and Total lymphoid irradiation (TLI) in people with Lymphoma, B-cell and Lymphoma, Non-Hodgkin, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to determine if double autologous then allogeneic hematopoietic cell transplant may offer an improved treatment option for patients with relapsed diffuse large B-cell lymphoma (DLBCL) who are not likely to be cured by the conventional transplantation regimen. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lymphoma, B-cell, Lymphoma, Non-Hodgkin, Diffuse Large B-cell Lymphoma (DLBCL)
- What is being tested?
- Autologous hematopoietic stem cell transplantation (auto-HSCT), Allogeneic hematopoietic stem cell transplantation (allo-HSCT) and Total lymphoid irradiation (TLI)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to May 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years.
- Histologically-proven diffuse large B-cell lymphoma (DLBCL) by the World Health Organization (WHO) classification.
- Relapse after achieving initial remission or failure to achieve initial remission. Patients with residual radiographic abnormalities after primary therapy are eligible if abnormalities are postive by fluorodeoxyglucose (FDG)-positron emission tomography (PET) (FDG-PET).
- Receipt of 2 cycles of second-line therapy and FDG-PET positive per Stanford (central) review. FDG-PET to be done 2 weeks after cycle 2 of second line chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status < 2
- Matched related or unrelated donor identified and available
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- Bone marrow biopsy and cytogenetic analysis within 8 weeks of registration
- Pretreatment serum bilirubin < 2 x the institutional upper limit of normal (ULN)
- Serum creatinine < 2 x the institutional ULN and measured or estimated creatinine clearance > 60 mL/min by the following formula (all tests must be performed within 28 days prior to registration):
- Estimated Creatinine Clearance = (140 age) x weight (kg) x 0.85 if female 72 x serum creatinine (mg/dL).
- EKG within 42 days prior to registration with no significant abnormalities suggestive of active cardiac disease
- Patients must have a radionuclide ejection fraction within 42 days of registration. If the ejection fraction is < 40%, the patient will not be eligible. If the ejection fraction is 40-50%, the patient will have a cardiology consult.
- Corrected diffusion capacity > 55%.
- Sexually active males are advised to use an accepted and effective method of birth control
- Women of child-bearing potential are advised to use an accepted and effective method of birth control
- Patients must sign and give written informed consent in accordance with institutional and federal guidelines. Patients must be informed of the investigational nature of this study.
Who cannot join
- Known allergy to etoposide or a history of Grade 3 hemorrhagic cystitis with cyclophosphamide
- Greater than Grade 2 sensory or motor peripheral neuropathy from prior vinca alkaloid use
- Requiring therapy for coronary artery disease, cardiomyopathy, dysrhythmia, or congestive heart failure
- Known to be human immunodeficiency virus (HIV)-positive. The antibody test for HIV must be performed within 42 days of registration.
- Prior chemotherapy other than corticosteroids administered within 2 weeks of the initiation of protocol therapy.
- Prior malignancy, except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the patients has been disease-free for five years.
Show all 19Show fewer
- Prior diagnosis of non-Hodgkin's lymphoma
- Active infection requiring oral or intravenous antibiotics
- Prior autologous or allogeneic hematopoietic cell transplantation
- Prior radioimmunotherapy
- Pregnant
- Lactating
- DONOR ELIGIBILITY
- Related or unrelated HLA-identical donors who are in good health and have no contra-indication to donation
- No contra-indication for the donor to collection by apheresis of mononuclear cells mobilized by G-CSF at a dose of 16 µg/kg of body weight.
- Donors will be evaluated with a full history and physical examination.
- Virology testing including HIV; cytomegalovirus (CMV); Epstein-Barr virus (EBV); human T-lymphotropic virus (HTLV); rapid plasma reagin (RPR); Hepatitis A, B and C be performed within 30 days of donation.
- Prospective donors will be screened for CMV seroreactivity and seronegative donors will be utilized if available.
- If more than one human leukocyte antigen (HLA)-matched related donor exists, then the donor will be selected on the basis of CD31 allotype.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: A Phase 2 Study in Poor Risk Diffuse Large B-cell Lymphoma of Total Lymphoid Irradiation & Antithymocyte Globulin Followed by Matched Allogeneic Hematopoietic Transplantation as Consolidation to Autologous Hematopoietic Cell Transplantation
The purpose of this study is to determine if double autologous then allogeneic hematopoietic cell transplant may offer an improved treatment option for patients with relapsed diffuse large B-cell lymphoma (DLBCL) who are not likely to be cured by the conventional transplantation regimen.
Read the detailed description
This study tests a tandem transplant approach that starts with transplantation of the participant's own hematopoietic (blood) cells, eg, autologous hematopoietic cell transplant (auto-HCT) as preparation for an subsequent matched-donor allogeneic HCT (allo-HCT).
Participants will be have progenitor cells (stem cells) mobilized into the peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim (G-CSF); undergo apheresis to collect autologous peripheral blood stem cells (PBSC, aka hematopoietic cells); and be re-infused with ≥ 3 x 10e6 CD34+ cells/kg (auto-HCT). Subsequently, participants will receive therapeutic, non-myeloablative chemotherapy (carmustine + cyclophosphamide + etoposide), then transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by ≥ 2 x 10e6 CD34+ cells/kg allogeneic PBSC obtained from a human leukocyte antigen (HLA)-matched or HLA single allele / antigen-mismatched donor (allo-HCT). Donors will be mobilized with 16 µg/kg filgrastim. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT infusion treatment includes cyclosporine and mycophenolate mofetil (MMF)
Subject's participation ends if a suitable matched donor is not identified within the 150 days.
Pre-medication treatments administered during this study may include acetaminophen; diphenhydramine; hydrocortisone; and methylprednisolone.
- Conditions
- Lymphoma, B-cell, Lymphoma, Non-Hodgkin, Diffuse Large B-cell Lymphoma (DLBCL), Malignant Lymphoma, Non-Hodgkin
- Being tested
- Autologous hematopoietic stem cell transplantation (auto-HSCT), Allogeneic hematopoietic stem cell transplantation (allo-HSCT), Total lymphoid irradiation (TLI), Rituximab, Carmustine
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous hematopoietic stem cell transplantation (auto-HSCT)Procedure or surgery
Also called Autologous peripheral blood progenitor cell (PBPC) transplantation
Auto-HCT involves an intravenous infusion of a participant's previously collected and frozen white blood cells collected after treatment with mobilizing agents
Allogeneic hematopoietic stem cell transplantation (allo-HSCT)Procedure or surgery
Also called Allogeneic peripheral blood progenitor cell (PBPC) transplantation
Allo-HCT involves an intravenous infusion of a donor's white blood cells collected after treatment with mobilization with filgrastim (G-CSF)
Total lymphoid irradiation (TLI)Procedure or surgery
TLI is administered in 80cGy fractions on Days -11 to Day-7 relative to allo-HSCT
RituximabDrug
Also called Rituxan, Mabthera
375 mg/m2 IV days 1 and 7 over 4 to 8 hours
CarmustineDrug
Also called BCNU, BiCNU
Based on body weight, unless its more than 15 kg greater than the idal body 15mg/kg (max dose 550 mg/m2) day -6 over 2 hours.
Males IBW = 50 kg + 2.3 kg/inch over 5 feet Females IBW = 45.5 kg + 2.3 kg/inch over 5 feet Adjusted IBW = IBW + 50% (actual weight - IBW)
EtoposideDrug
Also called Eposin, Etopophos, Vepesid, VP-16
60 mg/kg over 4 hours day -4 and alternatively VP-16 2 Gm/m² may be used (for mobilization)
FilgrastimDrug
Also called Granulocyte colony-stimulating factor (G-CSF, GCSF), Colony-stimulating factor 3 (CSF-3)
10 µg/kg/day subcutaneous starting Day 9 until last day of apheresis. 5 ug/kg actual body weight per day will be started at Day +6 after allo-HCT until hematologic recovery
Anti-thymocyte globulin (ATG)Drug
1.5 mg/kg/day for 5 days
CyclosporineDrug
Also called Cyclosporin, CSP
5.0 mg/kg twice daily from day -3 until after day +56
Mycophenolate mofetil (MMF)Drug
Also called CellCept
250 mg (total) twice daily, oral
15 mg/kg po on day 0, at 5-10 hours after mobilized PBPC infusion is complete. On day +1 MMF is taken at 15 mg/kg po b.i.d. (30 mg/kg/day) if transplantation was using a matched related donor and 15 mg/kg po t.i.d if from a matched unrelated donor or a one antigen mismatched donor.
CyclophosphamideDrug
Also called Cytoxan, Neosar
100 mg/kg will be administered over 2 hours on day -2
AcetaminophenDrug
Also called Tylenol
Pre-medication for rituximab and PBPC infusion. Administered at 650 mg by mouth 1 hour prior to infusion
DiphenhydramineDrug
Also called Benadryl
Pre-medication for rituximab and PBPC infusion. Administered at 50 mg intravenous 1 hour prior to infusion
HydrocortisoneDrug
Also called Cortef
Pre-medication for the PBPC infusion. Administered at 100 mg intravenous 1 hour prior to infusion
Also called Solu-Medrol
Anti-reaction medication for the ATG infusion. Administered at 1 mg/kg, Day-11 to Day-7
| Study group | Role | What they receive |
|---|---|---|
| Auto-HCT followed by Allo-HCT for Poor-risk DLBCL | Experimental | Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT).
Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF).
Subject's participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; \& methylprednisolone. Receives: Procedure: Autologous hematopoietic stem cell transplantation (auto-HSCT); Procedure: Allogeneic hematopoietic stem cell transplantation (allo-HSCT); Procedure: Total lymphoid irradiation (TLI); Drug: Rituximab; Drug: Carmustine; Drug: Etoposide; Drug: Filgrastim; Drug: Anti-thymocyte globulin (ATG); Drug: Cyclosporine; Drug: Mycophenolate mofetil (MMF); Drug: Cyclophosphamide; Drug: Acetaminophen; Drug: Diphenhydramine; Drug: Hydrocortisone; Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free Survival (EFS) Per Protocol
Event-free survival (EFS) through 4 years, as assessed in participants with poor-risk recurrent or primary refractory DLBCL treated with TLI and ATG followed by matched allogeneic hematopoietic cell transplantation as a consolidation to HCT. Event is defined as tumor progression or death.
Measured: 48 months
Secondary outcomes (6)
Median Time to Neutrophil Engraftment After Autologous Transplant
Reported as neutrophil engraftment after autologous transplant, defined as absolute neutrophil count (ANC) > 500/µL, counting from the day of transplant.
Measured: within 1 month
Median Time to Platelet Engraftment After Autologous Transplant
Reported as platelet engraftment after autologous transplant, defined as platelet count > 20,000/µL, counting from the day of transplant.
Measured: within 1 month
Median Time to Neutrophil Engraftment After Allogeneic Transplant
Reported as neutrophil engraftment after allogeneic transplant, defined as absolute neutrophil count (ANC) > 500/µL, counting from the day of transplant.
Measured: within 1 month
Median Time to Platelet Engraftment After Allogeneic Transplant
Reported as platelet engraftment after allogeneic transplant, defined as platelet count > 20,000/µL, counting from the day of transplant.
Measured: within 1 month
Incidence of Chronic Graft vs Host Disease (GvHD)
The incidence of chronic graft vs host disease (GvHD) is reported as any events within 3 years. Note that GvHD was assessed per investigator judgement. There was no protocol-specified criteria of GvHD.
Measured: 3 years
Overall Survival (OS)
To evaluate the overall and transplant related mortality rate, reported as the number of subjects remaining alive 3 years after transplant.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2007 (estimated)
- Study startOct 2006
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lymphoma, B-cellStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-Kai Weng, Stanford University
- Investigators
- Wen-Kai Weng, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482053
- Sponsor's protocol ID
- IRB-06703
- Other IDs
- 97355, BMT186
- Status last verified
- May 2018
- First submitted
- 31 May 2007
- Last updated
- 14 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study in Poor Risk Diffuse Large B-cell Lymphoma of Total Lymphoid Irradiation & Antithymocyte Globulin Followed by Matched Allogeneic Hematopoietic Transplantation as Consolidation to Autologous Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT00482053
- Acronym / sponsor ID
- IRB-06703
- Conditions
- Lymphoma, B-cell, Lymphoma, Non-Hodgkin, Diffuse Large B-cell Lymphoma (DLBCL), Malignant Lymphoma, Non-Hodgkin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 4 Jun 2007 (estimated)
- Results
- Posted 14 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if double autologous then allogeneic hematopoietic cell transplant may offer an improved treatment option for patients with relapsed diffuse large B-cell lymphoma (DLBCL) who are not likely to be cured by the conventional transplantation regimen.
Detailed description
This study tests a tandem transplant approach that starts with transplantation of the participant's own hematopoietic (blood) cells, eg, autologous hematopoietic cell transplant (auto-HCT) as preparation for an subsequent matched-donor allogeneic HCT (allo-HCT).
Participants will be have progenitor cells (stem cells) mobilized into the peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim (G-CSF); undergo apheresis to collect autologous peripheral blood stem cells (PBSC, aka hematopoietic cells); and be re-infused with ≥ 3 x 10e6 CD34+ cells/kg (auto-HCT). Subsequently, participants will receive therapeutic, non-myeloablative chemotherapy (carmustine + cyclophosphamide + etoposide), then transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by ≥ 2 x 10e6 CD34+ cells/kg allogeneic PBSC obtained from a human leukocyte antigen (HLA)-matched or HLA single allele / antigen-mismatched donor (allo-HCT). Donors will be mobilized with 16 µg/kg filgrastim. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT infusion treatment includes cyclosporine and mycophenolate mofetil (MMF)
Subject's participation ends if a suitable matched donor is not identified within the 150 days.
Pre-medication treatments administered during this study may include acetaminophen; diphenhydramine; hydrocortisone; and methylprednisolone.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Auto-HCT followed by Allo-HCT for Poor-risk DLBCL | Experimental | Procedure: Autologous hematopoietic stem cell transplantation (auto-HSCT), Procedure: Allogeneic hematopoietic stem cell transplantation (allo-HSCT), Procedure: Total lymphoid irradiation (TLI), Drug: Rituximab, Drug: Carmustine, Drug: Etoposide, Drug: Filgrastim, Drug: Anti-thymocyte globulin (ATG), Drug: Cyclosporine, Drug: Mycophenolate mofetil (MMF), Drug: Cyclophosphamide, Drug: Acetaminophen, Drug: Diphenhydramine, Drug: Hydrocortisone, Drug: MethylprednisoloneParticipants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT). Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF). Subject's participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; \& methylprednisolone. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age 18 to 70 years.
- Histologically-proven diffuse large B-cell lymphoma (DLBCL) by the World Health Organization (WHO) classification.
- Relapse after achieving initial remission or failure to achieve initial remission. Patients with residual radiographic abnormalities after primary therapy are eligible if abnormalities are postive by fluorodeoxyglucose (FDG)-positron emission tomography (PET) (FDG-PET).
- Receipt of 2 cycles of second-line therapy and FDG-PET positive per Stanford (central) review. FDG-PET to be done 2 weeks after cycle 2 of second line chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status < 2
Key exclusion criteria (19 listed)
- Known allergy to etoposide or a history of Grade 3 hemorrhagic cystitis with cyclophosphamide
- Greater than Grade 2 sensory or motor peripheral neuropathy from prior vinca alkaloid use
- Requiring therapy for coronary artery disease, cardiomyopathy, dysrhythmia, or congestive heart failure
- Known to be human immunodeficiency virus (HIV)-positive. The antibody test for HIV must be performed within 42 days of registration.
- Prior chemotherapy other than corticosteroids administered within 2 weeks of the initiation of protocol therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous hematopoietic stem cell transplantation (auto-HSCT)Also: Autologous peripheral blood progenitor cell (PBPC) transplantationAuto-HCT involves an intravenous infusion of a participant's previously collected and frozen white blood cells collected after treatment with mobilizing agents | Procedure or surgery | Auto-HCT followed by Allo-HCT for Poor-risk DLBCL |
| Allogeneic hematopoietic stem cell transplantation (allo-HSCT)Also: Allogeneic peripheral blood progenitor cell (PBPC) transplantationAllo-HCT involves an intravenous infusion of a donor's white blood cells collected after treatment with mobilization with filgrastim (G-CSF) | Procedure or surgery | Auto-HCT followed by Allo-HCT for Poor-risk DLBCL |
| Total lymphoid irradiation (TLI)TLI is administered in 80cGy fractions on Days -11 to Day-7 relative to allo-HSCT | Procedure or surgery | Auto-HCT followed by Allo-HCT for Poor-risk DLBCL |
| RituximabAlso: Rituxan, Mabthera375 mg/m2 IV days 1 and 7 over 4 to 8 hours | Drug | Auto-HCT followed by Allo-HCT for Poor-risk DLBCL |
| CarmustineAlso: BCNU, BiCNUBased on body weight, unless its more than 15 kg greater than the idal body 15mg/kg (max dose 550 mg/m2) day -6 over 2 hours. Males IBW = 50 kg + 2.3 kg/inch over 5 feet Females IBW = 45.5 kg + 2.3 kg/inch over 5 feet Adjusted IBW = IBW + 50% (actual weight - IBW) | Drug | Auto-HCT followed by Allo-HCT for Poor-risk DLBCL |
| EtoposideAlso: Eposin, Etopophos, Vepesid, VP-1660 mg/kg over 4 hours day -4 and alternatively VP-16 2 Gm/m² may be used (for mobilization) | Drug | Auto-HCT followed by Allo-HCT for Poor-risk DLBCL |
| FilgrastimAlso: Granulocyte colony-stimulating factor (G-CSF, GCSF), Colony-stimulating factor 3 (CSF-3)10 µg/kg/day subcutaneous starting Day 9 until last day of apheresis. 5 ug/kg actual body weight per day will be started at Day +6 after allo-HCT until hematologic recovery | Drug | Auto-HCT followed by Allo-HCT for Poor-risk DLBCL |
| Anti-thymocyte globulin (ATG)1.5 mg/kg/day for 5 days | Drug | Auto-HCT followed by Allo-HCT for Poor-risk DLBCL |
| CyclosporineAlso: Cyclosporin, CSP5.0 mg/kg twice daily from day -3 until after day +56 | Drug | Auto-HCT followed by Allo-HCT for Poor-risk DLBCL |
| Mycophenolate mofetil (MMF)Also: CellCept250 mg (total) twice daily, oral 15 mg/kg po on day 0, at 5-10 hours after mobilized PBPC infusion is complete. On day +1 MMF is taken at 15 mg/kg po b.i.d. (30 mg/kg/day) if transplantation was using a matched related donor and 15 mg/kg po t.i.d if from a matched unrelated donor or a one antigen mismatched donor. | Drug | Auto-HCT followed by Allo-HCT for Poor-risk DLBCL |
| CyclophosphamideAlso: Cytoxan, Neosar100 mg/kg will be administered over 2 hours on day -2 | Drug | Auto-HCT followed by Allo-HCT for Poor-risk DLBCL |
| AcetaminophenAlso: TylenolPre-medication for rituximab and PBPC infusion. Administered at 650 mg by mouth 1 hour prior to infusion | Drug | Auto-HCT followed by Allo-HCT for Poor-risk DLBCL |
| DiphenhydramineAlso: BenadrylPre-medication for rituximab and PBPC infusion. Administered at 50 mg intravenous 1 hour prior to infusion | Drug | Auto-HCT followed by Allo-HCT for Poor-risk DLBCL |
| HydrocortisoneAlso: CortefPre-medication for the PBPC infusion. Administered at 100 mg intravenous 1 hour prior to infusion | Drug | Auto-HCT followed by Allo-HCT for Poor-risk DLBCL |
| MethylprednisoloneAlso: Solu-MedrolAnti-reaction medication for the ATG infusion. Administered at 1 mg/kg, Day-11 to Day-7 | Drug | Auto-HCT followed by Allo-HCT for Poor-risk DLBCL |
Primary outcome
Event-free Survival (EFS) Per Protocol
Time frame: 48 months
Event-free survival (EFS) through 4 years, as assessed in participants with poor-risk recurrent or primary refractory DLBCL treated with TLI and ATG followed by matched allogeneic hematopoietic cell transplantation as a consolidation to HCT. Event is defined as tumor progression or death.
6 secondary outcomes
Median Time to Neutrophil Engraftment After Autologous Transplant
Time frame: within 1 month
Median Time to Platelet Engraftment After Autologous Transplant
Time frame: within 1 month
Median Time to Neutrophil Engraftment After Allogeneic Transplant
Time frame: within 1 month
Median Time to Platelet Engraftment After Allogeneic Transplant
Time frame: within 1 month
Incidence of Chronic Graft vs Host Disease (GvHD)
Time frame: 3 years
Overall Survival (OS)
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen-Kai Weng principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous hematopoietic stem cell transplantation (auto-HSCT), Allogeneic hematopoietic stem cell transplantation (allo-HSCT) and Total lymphoid irradiation (TLI) in people with Lymphoma, B-cell and Lymphoma, Non-Hodgkin, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free Survival (EFS) Per Protocol (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.