Blood CancerPhase 2NCT00185640

Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Anti-Thymocyte Globulin (ATG) for Older Patients With Hematologic Malignancies

A Phase 2 study testing Cyclosporine, Anti-thymocyte globulin (ATG) and Mycophenolate mofetil (MMF) in people with Blood Cancer and Leukemia, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To measure how frequently and to what degree a complication of transplant cell acute graft versus host disease (GvHD) occurs. Read more about this study

Who is it for?: Ages 50 to 70 years
Conditions the study is for: Blood Cancer, Leukemia
What is being tested?: Cyclosporine, Anti-thymocyte globulin (ATG) and Mycophenolate mofetil (MMF)
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: 303 participants
Where: 1 siteUnited States
Study dates: Mar 2003to Jan 2016
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 50 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Any patient with one of the following hematolymphoid malignancies or syndromes in whom allogeneic hematopoietic stem cell transplant (HST) is warranted. Specific disease categories include:
Indolent advanced stage non-Hodgkin lymphomas
Mantle cell lymphoma
Chronic lymphocytic leukemia
Hodgkin disease (Hodgkin's lymphoma)
Acute leukemias in complete remission

Show all 13Show fewer

Aplastic anemia
Paroxysmal nocturnal hemoglobinuria
Myelodysplastic or myeloproliferative syndromes.
Other selected malignancies/disorders may also be considered but must be approved by the transplant team and the Principal Investigator.
Age > 50 years, or if < 50 years of age, considered to be at high risk for regimen-related toxicity associated with conventional myeloablative transplants due to pre-existing medical conditions or prior therapy.
A fully human leukocyte antigen (HLA)-identical sibling or matched unrelated donor is available. Potential participants with one antigen mismatched donors can be considered but only after discussion with the transplant team and the Principal Investigator.
Participant must be competent to give consent.

Who cannot join

Progressive hematolymphoid malignancies despite conventional therapies, or acute leukemias not in complete remission.
Uncontrolled central nervous system (CNS) involvement with disease
Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
Pregnant
Cardiac ejection fraction < 30%
Uncontrolled cardiac failure

Show all 15Show fewer

Pulmonary diffusing capacity (DLCO) < 40% predicted
Elevation of bilirubin to > 3 mg/dL
Transaminases > 4 x the upper limit of normal
Creatinine clearance < 50 cc/min (24-hour urine collection)
Karnofsky performance score < 60%
Poorly controlled hypertension on multiple antihypertensives
Documented fungal disease that is progressive despite treatment
HIV-positive. Other viral infections, ie, Hepatitis B- and C- positive, evaluated on a case-by-case basis
Psychiatric disorders or psychosocial problems which in the opinion of the primary physician or Principal Investigator would place the patient at unacceptable risk from this regimen.

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University School of Medicine
Stanford, California, 94305

Other trials in United States

About this study

Official title: Allogeneic Hematopoietic Cell Transplantation Using a Non-Myeloablative Preparative Regimen of Total Lymphoid Irradiation and Anti-Thymocyte Globulin for Older Patients With Hematologic Malignancies

To measure how frequently and to what degree a complication of transplant cell acute graft versus host disease (GvHD) occurs.

Read the detailed description

This study evaluated whether TLI-ATG conditioning followed by allogeneic hematpoietic cell transplant (HCT), which has provided excellent overall survival for patients with relapsed lymphoma after failed autologous HCT, provides a similar benefit in the setting of elderly patients with hematologic malignancies.

Conditions: Blood Cancer, Leukemia
Being tested: Cyclosporine, Anti-thymocyte globulin (ATG), Mycophenolate mofetil (MMF), Filgrastim, Total Lymphoid Irradiation (TLI)
Medical subject headings: Hematologic Neoplasms, Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CyclosporineDrug
Also called Cyclosporin, Cyclosporin A
Starting day -3 at a dose of 5 mg/kg orally twice daily with a target trough level of 350 to 450 ng/mL
Anti-thymocyte globulin (ATG)Drug
Also called Thymoglobulin
1.5 mg/kg for total dose of 7.5mg/kg, IV starting on day -11 to day -7 before HCT
Mycophenolate mofetil (MMF)Drug
Also called CellCept
Begins on day 0 after HCT at a dose of 15 mg/kg. Transplant recipients who received related donor grafts received MMF twice daily and those who received unrelated donor grafts received MMF 3 times daily.
FilgrastimDrug
Also called Neupogen, Granulocyte-colony stimulating factor (G-CSF; GCSF), colony-stimulating factor 3 (CSF-3)
- Donors mobilized with 16 µg/kg/day filgrastim.
- As needed, myelosuppression in transplant recipients will be managed with subcutaneous filgrastim 5 µg/kg/day
Total Lymphoid Irradiation (TLI)Radiation
0.8 Gy/day from day -11 to day -7 (inclusive) from day -4 to day -2 (inclusive) with 2 additional fractions of 0.8 Gy delivered on day -1 for total dose of 8 Gy.

Study groups in NCT00185640
Study group	Role	What they receive
Non-myeloablative transplantation	Experimental	Pre-transplant total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG) infusion with Day 0 allogeneic hematopoietic cell transplant (HCT), followed by post-transplant immunosuppression by cyclosporine and mycophenolate mofetil. Receives: Drug: Cyclosporine; Drug: Anti-thymocyte globulin (ATG); Drug: Mycophenolate mofetil (MMF); Drug: Filgrastim; Radiation: Total Lymphoid Irradiation (TLI)

What is being measured

The primary outcome is the main question the study is designed to answer.

Acute Graft vs Host Disease (GvHD)
The incidence of acute GvHD after transplantation was assessed per Glucksberg GvHD grade, a compound scale based on the following combinations of disease stages.
Skin Stages
- 0: No rash
- 1: Maculopapular (MP) rash <25% of body surface area
- 2: MP rash on 25-50% of body surface area
- 3: Generalized erythroderma (ED)
- 4: Generalized ED with bullous formation and desquamation
Liver Stages (Bilirubin in mg/dL)
- 0: <2
- 1: 2-3
- 2: 3.01-6
- 3: 6.01-15.0
- 4: >15
Gastrointestinal (GI) Stages (diarrhea)
- 0: None or < 500 mL/day
- 1: 500-999 mL/day
- 2: 1000-1499 mL/day
- 3: >1500 mL/day
- 4: Severe abdominal pain, with or without ileus
Glucksberg Overall grade
- Grade 1: Skin 1/2; GI 0; Liver 0; Karnofsky performance scale (KPS) 90-100%
- Grade 2: Skin 1-3; GI 1; Liver 1; KPS 70-80
- Grade 2: Skin 2/3; GI 2/3; Liver 2-4; KPS 50-60
- Grade 4: Skin 2-4; GI 2-4; Liver 2-4; KPS 30-40
Measured: 100 days post-transplant

Secondary outcomes (5)

Acute Graft vs Host Disease (GvHD), All Evaluable
The incidence of acute GvHD after transplantation was assessed per Glucksberg GvHD grade, a compound scale based on the following combinations of disease stages.
Skin Stages
- 0: No rash
- 1: Maculopapular (MP) rash <25% of body surface area
- 2: MP rash on 25-50% of body surface area
- 3: Generalized erythroderma (ED)
- 4: Generalized ED with bullous formation and desquamation
Liver Stages (Bilirubin in mg/dL)
- 0: <2
- 1: 2-3
- 2: 3.01-6
- 3: 6.01-15.0
- 4: >15
Gastrointestinal (GI) Stages (diarrhea)
- 0: None or < 500 mL/day
- 1: 500-999 mL/day
- 2: 1000-1499 mL/day
- 3: >1500 mL/day
- 4: Severe abdominal pain, with or without ileus
Glucksberg Overall grade
- Grade 1: Skin 1/2; GI 0; Liver 0; Karnofsky performance scale (KPS) 90-100%
- Grade 2: Skin 1-3; GI 1; Liver 1; KPS 70-80
- Grade 2: Skin 2/3; GI 2/3; Liver 2-4; KPS 50-60
- Grade 4: Skin 2-4; GI 2-4; Liver 2-4; KPS 30-40
Measured: 100 days post-transplant
Incidence of Relapse
Reports the overall rate of disease relapse, occurring any time within 3 years after transplant
Measured: 3 years
Overall Survival (OS)
Measured: 3 and 5 years
Event-free Survival (EFS)
Reports the number and proportion of participants who neither died due to any cause nor experienced relapse.
Measured: 3 and 5 years
Transplant-related Mortality
Reports the proportion of participants who expired within 1 year due to any complication or failure of the transplant.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2003Jan 2016

First posted16 Sep 2005 (estimated)
Study startMar 2003
Primary completionApr 2014
Study completionJan 2016

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.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Blood CancerStudies 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: 303 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00185640
Sponsor's protocol ID: IRB-11960
Other IDs: 78998, BMT153
Status last verified: Jun 2021
First submitted: 12 Sep 2005
Last updated: 29 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Lowsky R, Takahashi T, Liu YP, Dejbakhsh-Jones S, Grumet FC, Shizuru JA, Laport GG, Stockerl-Goldstein KE, Johnston LJ, Hoppe RT, Bloch DA, Blume KG, Negrin RS, Strober S. Protective conditioning for acute graft-versus-host disease. N Engl J Med. 2005 Sep 29;353(13):1321-31. doi: 10.1056/NEJMoa050642.
PubMed 16192477
Jones CD, Arai S, Lowsky R, Tyan DB, Zehnder JL, Miklos DB. Complete donor T-cell engraftment 30 days after allogeneic transplantation predicts molecular remission in high-risk chronic lymphocytic leukaemia. Br J Haematol. 2010 Sep;150(5):637-9. doi: 10.1111/j.1365-2141.2010.08252.x. Epub 2010 Jun 7. No abstract available.
PubMed 20528878
Rezvani AR, Kanate AS, Efron B, Chhabra S, Kohrt HE, Shizuru JA, Laport GG, Miklos DB, Benjamin JE, Johnston LJ, Arai S, Weng WK, Negrin RS, Strober S, Lowsky R. Allogeneic hematopoietic cell transplantation after failed autologous transplant for lymphoma using TLI and anti-thymocyte globulin conditioning. Bone Marrow Transplant. 2015 Oct;50(10):1286-92. doi: 10.1038/bmt.2015.149. Epub 2015 Jul 6.
PubMed 26146806
Kohrt HE, Turnbull BB, Heydari K, Shizuru JA, Laport GG, Miklos DB, Johnston LJ, Arai S, Weng WK, Hoppe RT, Lavori PW, Blume KG, Negrin RS, Strober S, Lowsky R. TLI and ATG conditioning with low risk of graft-versus-host disease retains antitumor reactions after allogeneic hematopoietic cell transplantation from related and unrelated donors. Blood. 2009 Jul 30;114(5):1099-109. doi: 10.1182/blood-2009-03-211441. Epub 2009 May 7.
PubMed 19423725
Benjamin J, Chhabra S, Kohrt HE, Lavori P, Laport GG, Arai S, Johnston L, Miklos DB, Shizuru JA, Weng WK, Negrin RS, Lowsky R. Total lymphoid irradiation-antithymocyte globulin conditioning and allogeneic transplantation for patients with myelodysplastic syndromes and myeloproliferative neoplasms. Biol Blood Marrow Transplant. 2014 Jun;20(6):837-43. doi: 10.1016/j.bbmt.2014.02.023. Epub 2014 Mar 7.
PubMed 24607552

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma

All Blood Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Allogeneic Hematopoietic Cell Transplantation Using a Non-Myeloablative Preparative Regimen of Total Lymphoid Irradiation and Anti-Thymocyte Globulin for Older Patients With Hematologic Malignancies
ClinicalTrials.gov ID: NCT00185640
Acronym / sponsor ID: IRB-11960
Conditions: Blood Cancer, Leukemia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 303 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: Mar 2003
Primary completion: Apr 2014 (actual)
Study completion: Jan 2016 (actual)
First posted: 16 Sep 2005 (estimated)
Results: Posted 3 Oct 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To measure how frequently and to what degree a complication of transplant cell acute graft versus host disease (GvHD) occurs.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Non-myeloablative transplantation	Experimental	Drug: Cyclosporine, Drug: Anti-thymocyte globulin (ATG), Drug: Mycophenolate mofetil (MMF), Drug: Filgrastim, Radiation: Total Lymphoid Irradiation (TLI)Pre-transplant total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG) infusion with Day 0 allogeneic hematopoietic cell transplant (HCT), followed by post-transplant immunosuppression by cyclosporine and mycophenolate mofetil.

Who may qualify

Ages: 50 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Any patient with one of the following hematolymphoid malignancies or syndromes in whom allogeneic hematopoietic stem cell transplant (HST) is warranted. Specific disease categories include:
Age > 50 years, or if < 50 years of age, considered to be at high risk for regimen-related toxicity associated with conventional myeloablative transplants due to pre-existing medical conditions or prior therapy.
A fully human leukocyte antigen (HLA)-identical sibling or matched unrelated donor is available. Potential participants with one antigen mismatched donors can be considered but only after discussion with the transplant team and the Principal Investigator.
Participant must be competent to give consent.

Key exclusion criteria (15 listed)

Progressive hematolymphoid malignancies despite conventional therapies, or acute leukemias not in complete remission.
Uncontrolled central nervous system (CNS) involvement with disease
Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
Pregnant
Cardiac ejection fraction < 30%

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
CyclosporineAlso: Cyclosporin, Cyclosporin AStarting day -3 at a dose of 5 mg/kg orally twice daily with a target trough level of 350 to 450 ng/mL	Drug	Non-myeloablative transplantation
Anti-thymocyte globulin (ATG)Also: Thymoglobulin1.5 mg/kg for total dose of 7.5mg/kg, IV starting on day -11 to day -7 before HCT	Drug	Non-myeloablative transplantation
Mycophenolate mofetil (MMF)Also: CellCeptBegins on day 0 after HCT at a dose of 15 mg/kg. Transplant recipients who received related donor grafts received MMF twice daily and those who received unrelated donor grafts received MMF 3 times daily.	Drug	Non-myeloablative transplantation
FilgrastimAlso: Neupogen, Granulocyte-colony stimulating factor (G-CSF; GCSF), colony-stimulating factor 3 (CSF-3)* Donors mobilized with 16 µg/kg/day filgrastim. * As needed, myelosuppression in transplant recipients will be managed with subcutaneous filgrastim 5 µg/kg/day	Drug	Non-myeloablative transplantation
Total Lymphoid Irradiation (TLI)0.8 Gy/day from day -11 to day -7 (inclusive) from day -4 to day -2 (inclusive) with 2 additional fractions of 0.8 Gy delivered on day -1 for total dose of 8 Gy.	Radiation	Non-myeloablative transplantation

Primary outcome

Acute Graft vs Host Disease (GvHD)
Time frame: 100 days post-transplant
The incidence of acute GvHD after transplantation was assessed per Glucksberg GvHD grade, a compound scale based on the following combinations of disease stages. Skin Stages * 0: No rash * 1: Maculopapular (MP) rash <25% of body surface area * 2: MP rash on 25-50% of body surface area * 3: Generalized erythroderma (ED) * 4: Generalized ED with bullous formation and desquamation Liver Stages (Bilirubin in mg/dL) * 0: <2 * 1: 2-3 * 2: 3.01-6 * 3: 6.01-15.0 * 4: >15 Gastrointestinal (GI) Stages (diarrhea) * 0: None or < 500 mL/day * 1: 500-999 mL/day * 2: 1000-1499 mL/day * 3: >1500 mL/day * 4: Severe abdominal pain, with or without ileus Glucksberg Overall grade * Grade 1: Skin 1/2; GI 0; Liver 0; Karnofsky performance scale (KPS) 90-100% * Grade 2: Skin 1-3; GI 1; Liver 1; KPS 70-80 * Grade 2: Skin 2/3; GI 2/3; Liver 2-4; KPS 50-60 * Grade 4: Skin 2-4; GI 2-4; Liver 2-4; KPS 30-40

5 secondary outcomes

Acute Graft vs Host Disease (GvHD), All Evaluable
Time frame: 100 days post-transplant
Incidence of Relapse
Time frame: 3 years
Overall Survival (OS)
Time frame: 3 and 5 years
Event-free Survival (EFS)
Time frame: 3 and 5 years
Transplant-related Mortality
Time frame: 1 year

Results and safety

Results posted to the registry on 3 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Non-myeloablative Transplantation	303	158

Primary outcome: Acute Graft vs Host Disease (GvHD)

Time frame: 100 days post-transplant. Number. Unit: percentage of participants

Measure	Non-myeloablative Transplantation n = 37
Value	2.7

Population analysed: Reports the incidence of Grades 2 to 4 acute GvHD, as observed for the initial 37 participants treated on this study, who constitute the Primary Analysis for the study. See linked citation Lowsky, et al. NEJM. 29Sep2005;353(13)1321-1331.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Non-myeloablative Transplantation	138 of 303 (45.5%)	55 of 303 (18.2%)	138 of 303

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 16192477Lowsky R, Takahashi T, Liu YP, Dejbakhsh-Jones S, Grumet FC, Shizuru JA, Laport GG, Stockerl-Goldstein KE, Johnston LJ, Hoppe RT, Bloch DA, Blume KG, Negrin RS, Strober S. Protective conditioning for acute graft-versus-host disease. N Engl J Med. 2005 Sep 29;353(13):1321-31. doi: 10.1056/NEJMoa050642.
Results publication: PubMed 20528878Jones CD, Arai S, Lowsky R, Tyan DB, Zehnder JL, Miklos DB. Complete donor T-cell engraftment 30 days after allogeneic transplantation predicts molecular remission in high-risk chronic lymphocytic leukaemia. Br J Haematol. 2010 Sep;150(5):637-9. doi: 10.1111/j.1365-2141.2010.08252.x. Epub 2010 Jun 7. No abstract available.
Results publication: PubMed 26146806Rezvani AR, Kanate AS, Efron B, Chhabra S, Kohrt HE, Shizuru JA, Laport GG, Miklos DB, Benjamin JE, Johnston LJ, Arai S, Weng WK, Negrin RS, Strober S, Lowsky R. Allogeneic hematopoietic cell transplantation after failed autologous transplant for lymphoma using TLI and anti-thymocyte globulin conditioning. Bone Marrow Transplant. 2015 Oct;50(10):1286-92. doi: 10.1038/bmt.2015.149. Epub 2015 Jul 6.
Results publication: PubMed 19423725Kohrt HE, Turnbull BB, Heydari K, Shizuru JA, Laport GG, Miklos DB, Johnston LJ, Arai S, Weng WK, Hoppe RT, Lavori PW, Blume KG, Negrin RS, Strober S, Lowsky R. TLI and ATG conditioning with low risk of graft-versus-host disease retains antitumor reactions after allogeneic hematopoietic cell transplantation from related and unrelated donors. Blood. 2009 Jul 30;114(5):1099-109. doi: 10.1182/blood-2009-03-211441. Epub 2009 May 7.
Results publication: PubMed 24607552Benjamin J, Chhabra S, Kohrt HE, Lavori P, Laport GG, Arai S, Johnston L, Miklos DB, Shizuru JA, Weng WK, Negrin RS, Lowsky R. Total lymphoid irradiation-antithymocyte globulin conditioning and allogeneic transplantation for patients with myelodysplastic syndromes and myeloproliferative neoplasms. Biol Blood Marrow Transplant. 2014 Jun;20(6):837-43. doi: 10.1016/j.bbmt.2014.02.023. Epub 2014 Mar 7.
Individual participant dataSharing planned: No

Related trials for Blood Cancer

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma

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.

Robert Lowsky 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 Cyclosporine, Anti-thymocyte globulin (ATG) and Mycophenolate mofetil (MMF) in people with Blood Cancer and Leukemia, 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 13 inclusion and 15 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: finished, as of the sponsor's last update on 29 Jun 2021. 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 3 Oct 2017). 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?

Acute Graft vs Host Disease (GvHD) (time frame: 100 days post-transplant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00185640, which also lists 5 linked publications.

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 29 Jun 2021.